Contains Nonbinding Recommendations 
Pediatric Information for X-ray 
Imaging Device Premarket 
Notifications 
Guidance for Industry and  
Food and Drug Administration Staff  
Document issued on November 28, 2017.  
The draft of this document was issued on May 10, 2012. 
For questions about this document, contact the Office of In Vitro Diagnostics and Radiological 
Health at 240-402-5149 and Laurel Burk at 301-796-5933 or Laurel.Burk@fda.hhs.gov.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
 
Office of In Vitro Diagnostics and Radiological Health (OIR) 
Division of Radiological Health 
 
  1  Contains Nonbinding Recommendations 
 
 
Preface 
 
Public Comment 
 
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, 
Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 
20852. Identify all comments with the docket number FDA-2012-D-0384.  Comments may not 
be acted upon by the Agency until the document is next revised or updated. 
 
Additional Copies 
 
Additional copies are available from the Internet. You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document 
number 1771 to identify the guidance you are requesting.  Contains Nonbinding Recommendations 
 
Table of Contents 
 
 
I.  Introduction .................................................................................................................................................... 1 
II.  Background ............................................................................................................................................... 2 
A.  Public Health Motivation .......................................................................................................................... 2 
B.  Past FDA Actions, Guidance and Public Meetings ................................................................................... 4 
C.  The Approach of this Guidance ................................................................................................................. 5 
III.  Scope ......................................................................................................................................................... 5 
IV.  Pediatric Population .................................................................................................................................. 6 
V.  Indications for Use .................................................................................................................................... 8 
VI.  Risk Assessment ........................................................................................................................................ 8 
VII.  Pediatric Device Features .......................................................................................................................... 9 
VIII.  Protocols .................................................................................................................................................. 11 
IX.  Laboratory Image Quality and Dose Assessment .................................................................................... 12 
X.  Clinical Image Quality Assessment ......................................................................................................... 13 
XI.  Labeling ................................................................................................................................................... 14 
A.  Pediatric Summary Section ..................................................................................................................... 14 
B.  Contraindications, Warnings, and Precautions ........................................................................................ 14 
C.  Device Description .................................................................................................................................. 15 
D.  Instructions for Use ................................................................................................................................. 15 
E.  Quality Control Testing Recommendations ............................................................................................ 16 
F.  Additional Information ............................................................................................................................ 16 
XII.  Training and Testing Materials for Users and Manufacturers' Personnel ................................................ 16 
Appendix A: Pediatric Summary Section for Instructions for Use ....................................................................... 18 
Appendix B: General Laboratory Image Quality and Dose Assessment, Tests and Standards ............................ 20 
  Contains Nonbinding Recommendations 
Pediatric Information for X-ray 
Imaging Device Premarket 
Notifications 
 
 
Guidance for Industry and  
Food and Drug Administration Staff  
 
This guidance represents the current thinking of the Food and Drug Administration (FDA 
or Agency) on this topic.  It does not establish any rights for any person and is not binding 
on FDA or the public.  You can use an alternative approach if it satisfies the requirements 
of the applicable statutes and regulations.  To discuss an alternative approach, contact the 
FDA staff or Office responsible for this guidance as listed on the title page.  
 
I.  Introduction 
 
This guidance document outlines the current thinking of the Food and Drug Administration 
(FDA or the Agency) regarding information that should be provided in premarket notification 
submissions (510(k)s) and device labeling for x-ray imaging devices that are indicated for 
pediatric populations or general use x-ray imaging devices for which considerable pediatric 
application is anticipated. General use x-ray imaging devices typically neither include nor 
exclude specific populations in the indications for use and may be expected to be used in any 
population  Because a large percentage of the hundreds of millions of x-ray examinations 
performed annually in the US are exams of pediatric patients1, FDA expects that most 
general use x-ray imaging devices will be used for a considerable quantity of pediatric 
examinations unless a devices design precludes use in smaller sized patients.  This guidance 
is intended to enhance clarity regarding the premarket review process of 510(k)s for x-ray 
imaging devices, to encourage the inclusion of pediatric indications for use for x-ray imaging 
device premarket notifications, and to provide recommendations regarding labeling, 
including the instructions for use. 
 
X-ray imaging devices are subject not only to the medical device requirements in the Federal 
Food, Drug, and Cosmetic Act (FD&C Act), but are also electronic products under section 
                                                           
1 Analysis by the National Council of Radiation Protection and Measurements in NCRP Report No. 160, 
Ionizing Radiation Exposure of the Population of the United States, estimates that pediatric populations make 
up approximately 8% of total CT examinations and 15% of radiographic fluoroscopy examinations, for 
example. 
  1  Contains Nonbinding Recommendations 
531(2) of Subchapter C (Electronic Product Radiation Control (EPRC)) of the FD&C Act.  
As such, X-ray imaging devices are subject to the radiological health requirements in Title 
21, Subchapter J, Parts 1000 through 1050 of the Code of Federal Regulations (CFR), 
including applicability of general and specific performance standards (21 CFR Parts 1010-
1050) and other general requirements for reporting and recordkeeping (21 CFR Part 1002), 
notification and corrective actions for defective or non-compliant electronic products (21 
CFR Parts 1003 and 1004), and importation (21 CFR Part 1005).  For additional information, 
see in particular 21 CFR 1020.30-1020.33 (Diagnostic x-ray systems and their major 
components; Radiographic equipment; Fluoroscopic equipment; and Computed 
tomography (CT) equipment) as applicable. 
 
For the current edition of the FDA-recognized standard(s) referenced in this document, see 
the FDA Recognized Consensus Standards Database Web site at 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.   
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited. The use of the word should in Agency guidance means that 
something is suggested or recommended, but not required.   
II.  Background 
A.  Public Health Motivation 
 
Like all other medical procedures, x-ray imaging exams present both benefits and risks. 
These imaging procedures have led to improvements in the diagnosis and treatment of 
numerous medical conditions. At the same time, these types of exams expose patients to 
ionizing radiation, which may elevate a persons lifetime risk of developing cancer. Exposure 
to ionizing radiation is of particular concern in pediatric patients for three reasons: 1) 
younger patients are more radiosensitive than adults (i.e., the cancer risk per unit dose of 
ionizing radiation is higher for younger patients);2 2) younger patients have a longer expected 
lifetime for the effects of radiation exposure to manifest as cancer; and 3) use of equipment 
and exposure settings designed for adult use can result in excessive radiation exposure to the 
smaller patient. The third point is of special concern because many pediatric imaging exams 
are performed in facilities where pediatric imaging is not a majority of the workload.3 
 
                                                           
2NAS National Research Council Committee to Assess Health Risks from Exposure to Low Levels of Ionizing 
Radiation. 2006. Health risks from exposure to low levels of ionizing radiation: BEIR VII phase 2. Washington, 
D.C.: National Academy of Sciences, National Academies Press. 
3
Larson, D.B. et al., Rising Use of CT in Child Visits to the Emergency Department in the United States, 
1995-2008, Radiology, vol. 259(3), pp. 793-801, 2011. 
 
  2  Contains Nonbinding Recommendations 
FDA strives to promote increased patient safety in medical imaging through two principles of 
radiation protection developed by the International Commission on Radiological Protection4:  
 
  Justification: Examinations using ionizing radiation should be performed only when 
necessary to answer a medical question, help treat a disease, or guide a procedure.  
  Dose Optimization: Examinations should use techniques that are adjusted to administer 
the lowest radiation dose that yields an image quality adequate for diagnosis or 
intervention (i.e., radiation doses should be "As Low as Reasonably Achievable").  
 
Manufacturers of x-ray imaging devices are encouraged to promote dose optimization by 
designing their devices for optimal safe use and including dose-optimization information to 
end users in the labeling. This guidance focuses on recommendations to manufacturers for 
device features and instructions that would help medical professionals optimize radiation 
dose in x-ray imaging exams for pediatric patients.   
 
Currently, many x-ray imaging devices are marketed with a general indications for use 
(IFU)5 statement6, and the use of the device is not limited to a specific population.  The 
majority of these devices are expected to be used in a considerable number of pediatric 
patient imaging applications. However, experts have commented that many general use x-ray 
imaging devices are sold without features or labeling information that would help users to 
optimize clinically usable image quality in comparison to radiation exposure for use in 
pediatric imaging.7   
 
Imaging professionals can safely use existing x-ray equipment without specific features or 
instructions for pediatric use by consulting recommendations provided by the Alliance for 
Radiation Safety in Pediatric Imaging (Image Gently Alliance)8 and other organizations. 
FDA has reviewed the recommendations from the Image Gently Alliance and believes they 
are appropriate. However, FDA has received public comments that it can be challenging for 
imaging professionals to apply these recommendations without additional information from 
the manufacturer because x-ray imaging systems can be complex with a broad range of 
available settings.  Accordingly, FDA believes that safety can be further improved if x-ray 
                                                           
4The principles of radiation protection in medicine, including "optimization" and the ALARA principle are 
described in: International Commission on Radiological Protection. 2007. ICRP Publication 105: Radiological 
Protection in Medicine. Ann. ICRP, 37(6), and NCRP. Limitation of exposure to ionizing radiation. NCRP 
Report No. 116. Bethesda, MD: National Council on Radiation Protection and Measurements, 1993. These 
principles are also emphasized in the federal guidance: Interagency Working Group on Medical Radiation. 
Federal Guidance Report No. 14. Radiation Protection Guidance for Diagnostic and Interventional X-Ray 
Procedures. Washington, DC: Environmental Protection Agency, 2014 .  
5See FDA;s guidance entitled General/Specific Intended Use 
(http://www.fda.gov/downloads/MedicalDevices/ 
DeviceRegulationandGuidance/GuidanceDocuments/ucm073945.pdf). 
6See FDAs guidance entitled The 510(k) Program: Evaluating Substantial Equivalence in Premarket 
Notifications [510(k)] Guidance for Industry and Food and Drug Administration Staff 
(https://www.fda.gov/downloads/MedicalDevices/.../UCM284443.pdf). 
7See public comments to 2010 FDAs public meeting on Device Improvements to Reduce Unnecessary 
Radiation Exposure from Medical Imaging  (https://www.regulations.gov/document?D=FDA-2010-N-0080-
0001). 
8http://www.imagegently.org/   
  3  Contains Nonbinding Recommendations 
imaging devices include additional design features and information for users that facilitate 
choosing optimized equipment settings for pediatric patients. Because of the heightened 
concerns about excessive exposure to radiation in children, FDA believes that new x-ray 
imaging devices should include clear information for the end user on the design features and 
instructions available for imaging patients outside the typical adult size range. FDA 
recommends that in order to minimize the risk of excessive exposure of radiation to children, 
manufacturers of x-ray imaging devices should, as part of their device design, peform a risk 
assessment that considers specific risks and mitigations arising from the use of their device in 
pediatric populations. With appropriate instructions, safety information, and a description of 
available pediatric-specific features, the end user can then make more informed decisions 
about use of the device on pediatric patients.    
 
B.  Past FDA Actions, Guidance and Public Meetings 
 
In 2007, Congress passed the Food and Drug Administration Amendments Act of 2007 
(FDAAA) (Pub. L. 110-85) that included Title III, the Pediatric Medical Device Safety and 
Improvement Act (PMDSIA). PMDSIA requires submission of information on pediatric 
subpopulations that suffer from the disease or condition that the device is intended to treat, 
diagnose, or cure for certain types of device applications and supplements  
 
In February 2010, the FDA launched an "Initiative to Reduce Unnecessary Radiation 
Exposure from Medical Imaging"9 and on March 30-31, 2010, the Agency held a public 
meeting entitled Device Improvements to Reduce Unnecessary Radiation Exposure from 
Medical Imaging.10  At the meeting, the FDA sought advice on "steps that manufacturers of 
CT and fluoroscopic devices could take to reduce unnecessary radiation exposure through 
improved product design, enhanced labeling, or improved instructions and training for 
equipment use and quality assurance at medical imaging facilities."11 The Agency asked 
whether manufacturers should incorporate special provisions for pediatric patients, 
particularly with regard to hardware and software features.12  Recommendations received by 
FDA, which apply to all general-use x-ray imaging modalities, included making available 
pediatric protocols and control settings, targeted instructions and educational materials 
emphasizing pediatric dose reduction, quality assurance tools for facilities emphasizing 
radiation dose management, and dose information applicable to pediatric patients. Many of 
the recommendations from pediatric experts focused on expanding the flexibility or range of 
features already available on x-ray imaging devices, which may also improve adult imaging 
for non-standard applications.  
 
                                                           
9http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm2007191.htm  
10Agenda and transcripts available at: https://www.federalregister.gov/documents/2010/02/24/2010-
3674/device-improvements-to-reduce-unnecessary-radiation-exposure-from-medical-imaging-public-meeting. 
Public docket submissions are available at: https://www.regulations.gov/document?D=FDA-2010-N-0080-
0001. 
11See 75 FR 8375, 8376 (Feb. 24, 2010). 
12 The Federal Register Notice lists all the questions asked at the meeting (see 75 FR 8375-8377 (2010)). 
 
  4  Contains Nonbinding Recommendations 
On July 16, 2012, the Agency held a public meeting entitled "Device Improvements for 
Pediatric X-ray Imaging."13 At the meeting, FDA solicited public feedback on the draft of 
this guidance and requested help in identifying issues relevant to radiation safety in pediatric 
x-ray imaging that might benefit from standards development or further research. FDA 
requested specific comments on technical device design and pediatric safety questions. Since 
the 2012 meeting, many recommended device design improvements have been incorporated 
into FDA-recognized consensus standards and others are under consideration for future 
revisions of such standards.  See Appendix B for a discussion of some relevant international 
consensus standards. 
 
In 2014, the Agency issued a revised general pediatric guidance entitled Premarket 
Assessment of Pediatric Medical Devices14. The guidance, which applies to all devices, 
defines pediatric subpopulations and the general information that should be provided for 
different types of premarket submissions for devices intended for use in pediatric 
populations. 
 
C.  The Approach of this Guidance 
 
This guidance provides recommendations on the information that should be included in 
premarket notifications for x-ray imaging devices that are indicated for pediatric populations 
or general use x-ray imaging devices for which considerable pediatric application is 
anticipated. Manufacturers seeking marketing clearance for a new x-ray imaging device that 
could be used in pediatric populations should address pediatric use in their risk assessment 
and provide mitigations where approriate, regardless of whether the device has a specific 
pediatric indication. While including pediatric use is an important part of the risk assessment 
for all general use x-ray imaging devices15, other parts of this guidance may only be 
applicable to certain devices. This guidance offers a framework for how manufacturers may 
address pediatric x-ray safety concerns in design, testing, and labeling of their device, but 
any specific device design issues discussed are provided only as a reference.  FDA believes 
that development of, and conformance to, device-specific voluntary consensus standards, 
such as those discussed in Appendix B, can help to ensure implementation of x-ray device-
specific pediatric safety design features industry-wide.  
 
III.  Scope 
 
                                                           
13 Please refer to the following URL for a summary of the meeting, specific questions and topics on which the 
Agency requested public comment, and the list of comments received: 
https://www.regulations.gov/document?D=FDA-2012-N-0385-0002. 
14Premarket Assessment of Pediatric Medical Devices - Guidance for Industry and Food and Drug 
Administration Staff:  
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm.  
15 These devices typically do not include specific populations in the indications for use and may be expected to 
be used in any population. 
 
  5  Contains Nonbinding Recommendations 
This guidance document is generally applicable to all x-ray imaging devices that are 
specifically indicated for pediatric use or general use x-ray imaging devices for which 
considerable pediatric application is anticipated.  Both new devices and modifications of 
existing x-ray imaging devices which require submission of a new premarket notification16 
are included within the scope of this guidance document, regardless of whether the device is 
a complete x-ray imaging system, a component part of an x-ray imaging device or an 
accessory (e.g., detectors and software).   
 
This guidance provides a broad framework regarding the information which should be 
submitted to support premarket submissions for x-ray imaging devices indicated for pediatric 
populations and general use x-ray imaging devices for which considerable pediatric 
application is anticipated. While Section V (Indications for Use), Section VI (Risk 
Assessment), and Section XI (Labeling) are generally applicable to all x-ray imaging devices, 
other portions of the guidance document may only be applicable to certain devices.  In 
particular, Section VII (Pediatric Device Features) contains specific information about 
device features that are only applicable to certain devices. For feedback about which 
information may be applicable to a particular x-ray imaging device, FDA recommends that 
manufacturers submit a Pre-submission.17 
 
This guidance should be used in conjunction with device-specific guidance documents 
addressing premarket notification requirements and serves as a supplement to the general 
guidance document on the content and format of a 510(k) submission.18,19   
 
IV.  Pediatric Population  
 
The FDA's Center for Devices and Radiological Health defines the age range of the pediatric 
population as birth through 21 years.20  While the risk of radiation-induced cancer depends 
                                                           
16See FDA guidance on Deciding When to Submit a 510(k) for a Change to an Existing Device 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm). 
17 For information on how to submit a pre-submission, see FDAs guidance entitled Requests for Feedback on 
Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration 
Staff. 
(https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM31
1176.pdf). 
18Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s 
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm084365.htm)
. 
19The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] 
(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM28
4443.pdf). 
20See FDAs guidance entitled Premarket Assessment of Pediatric Medical Devices 
(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM08
9742.pdf). Suggested age ranges in this guidance are: neonate (birth-1 month), infant (1 month-2 yrs.), child 
(2-12 yrs.), adolescent (12-21 yrs.). The subgroups suggested in this guidance are consistent with these age 
ranges. 
 
  6  Contains Nonbinding Recommendations 
on age21, patient size (i.e., height, weight, body part thickness) is a more important factor 
than age for optimizing image quality and radiation dose for x-ray imaging exams.22  
Because the focus of this guidance is on device design, labeling, and evaluation of x-ray 
imaging devices, this guidance recommends division of the pediatric population into 
subgroups based on patient size rather than age.   
 
Pediatric patients can range in weight from less than 500 grams (1 lb) to more than 120 kg 
(265 lb). As a result, a device designed for pediatric use (across all pediatric population 
subgroups) will also be adequate for the entire size range of the general adult population; 
conversely, devices designed only for adults may not be optimized for use on many smaller 
patients. For example, the 5th percentile U.S. adult female [51 kg (112 lb.); 151 cm (59 in) 
standing height] is similar in size to an average 12 year old.23 A well-designed adult device 
that takes account of a broad individual size variation should be able to competently image 
average pediatric patients 12 years old and above, but would not necessarily address the 
needs of younger pediatric patients.  Due to this size overlap between smaller adults and 
older pediatric patients, many of the recommendations in the following sections are expected 
to also improve imaging of smaller adults.   
 
In the design of x-ray imaging devices, we recommend that manufacturers consider 
subgroups that are appropriate to the intended use of their device.  Depending on the body 
part imaged, the appropriate subgroups will be different. While body part thickness is the 
most relevant metric for x-ray imaging of individual patients,24,25 age and size may be more 
readily available metrics for describing average patients. It may therefore be appropriate to 
consider the applicable body part thickness corresponding to the following pediatric 
subgroups, defined according to age and approximate average height and weight 
measurements, which may be appropriate for body imaging: neonate/birth-1 month [1-2 kg 
                                                           
21Based on reports of the lifetime incidence of cancer vs. age of exposure data, the pediatric subgroups defined 
by the Agency in the guidance entitled Premarket Assessment of Pediatric Medical Devices cover the region 
where the largest age dependence is expected for cancer risk. Risk decreases much less steeply as a function of 
age for individuals over 21 years of age. [See NAS National Research Council Committee to Assess Health 
Risks from Exposure to Low Levels of Ionizing Radiation. 2006. Health risks from exposure to low levels of 
ionizing radiation: BEIR VII phase 2. Washington, D.C.: National Academy of Sciences, National Academies 
Press.] 
22Watson DJ, Coakley KS. Paediatric CT reference doses based on weight and CT dosimetry phantom size: 
local experience using a 64-slice CT scanner. Pediatr Radiol. 2010;40(5):693-703, and Jarvinen H, Seuri R, 
Kortesniemi M, et al. Indication-based national diagnostic reference levels for paediatric CT: a new approach 
with proposed values. Radiat Prot Dosim. 2015;165(1-4):86-90. 
23 McDowell, M.A., C.D. Fryar, C.L. Ogden, and K. M. Flegal. 2008. Anthropomorphic Reference Data for 
Children and Adults, United States, 2003-2006. National Health Statistics Reports, 10, 1-48. Available for 
download at: http://www.cdc.gov/nchs/data/nhsr/nhsr010.pdf.   
24The following reference gives current data for anteroposterior and transverse body diameter for pediatric 
patients ranging in age from 0.5 to 20 years: Kleinman, P. L., K. J. Strauss, D. Zurakowski, K. S. Buckley, and 
G. A. Taylor. 2010. Patient size measured as a function of age at a tertiary care children's hospital. American 
Journal of Roentgenology, 194, 1611-1619.  
25The following reference used cylindrical phantoms with diameters of 8, 16, 24, and 32 cm to represent a 
neonate, 5 year old, 12 year old, and adult patient respectively: Siegel, M. J., et al. 2004. Radiation dose and 
image quality in pediatric CT: effect of technical factors and phantom size and shape. Radiology, 233(2), 515-
522.  
 
  7  Contains Nonbinding Recommendations 
(2.2-4.4 lb) low end estimate], 1 year old [~11 kg (24 lb); recumbent length 100 cm (39.4 
in.)], 5 year old [~21 kg (46 lb); 113 cm (44.5 in) standing height], 12 year old [~52 kg (115 
lb); 156 cm (61.5 in) standing height] and adult [~80 kg (176 lb); standing height 170 cm 
(67.0 in)]26. Subgroups for head imaging, where it is appropriate to define groups based on 
patient age, should include the following: 0-1 year, 1-2 years, 2-6 years, 6-16 years, and 16+ 
years.27 
 
The above subgroups are listed as a general guide.  Different subgroups that still cover the 
broad size range expected for pediatric patients may be appropriate depending on the 
intended use of the x-ray imaging device.28 
V.  Indications for Use  
 
The 510(k) submission should clearly define the indication(s) for use (IFU), including all 
populations for whom the device is intended. When the needs of pediatric patients are 
specifically considered in the design and features of a device, the indications for use should 
specify the pediatric populations in which the device is intended to be used. When a device 
does not include specialized design features for pediatric populations and is intended to be 
used across a broad population range, the Indications for Use should state that the device is 
intended for general populations. For devices intended only for adult use,  we recommend 
that you clearly state this as part of your IFU statement.   For example, although most x-ray 
imaging devices for general use may be safely used in pediatric populations, some 
circumstances exist where restrictions on pediatric populations may be appropriate. One 
example may be extremity-only cone beam CT scanners designed for adult patients, if safety 
features do not exist to prevent radiation exposure outside the anatomy of interest when the 
patient falls outside the typical adult size range.  
 
VI.  Risk Assessment  
 
                                                           
26 Size measurements are based on approximate mean values (averaged across males and females) from: 
McDowell, M.A., C.D. Fryar, C.L. Ogden, and K. M. Flegal. 2008. Anthropomorphic Reference Data for 
Children and Adults, United States, 2003-2006. National Health Statistics Reports, 10, 1-48. The weight given 
for the neonate subgroup is lower than the average to ensure that a broad range of sizes is adequately covered. 
27These age ranges differ from those suggested for body imaging due to the difference in the growth rate of the 
head; the age ranges cited are those that appear in the American Association of Physicists in Medicine (AAPM) 
sample head protocols for pediatric patients: Pediatric Routine Head CT Protocols Version 1.1, AAPM Alliance 
for Quality Computed Tomography. 
28 For example, the following weight groups are used both in the European Guidelines on Diagnostic Reference 
Levels for Pediatric Imaging and approximate equivalent ages (European Commission. European Guidelines on 
Diagnostic Reference Levels for Paediatric Imaging, Radiation Protection 185. 2016.  (European Union: 
Luxembourg) and in the ICRP Diagnostic Reference Levels in Medical Imaging (ICRP Ref 4836-8337-6684, 
Draft published January 11, 2016) [Grouping Name (weight, age)]: Neonate (< 5 kg, < 1 m); Infant, toddler and 
early childhood (5 - < 15 kg, 1 m - < 4 y); Middle childhood (15 - < 30 kg, 4 - < 10 y); early adolescence (30 - < 
50 kg, 10 - < 14 y); late adolescence (50 - < 80 kg, 14 - < 18 y). 
 
  8  Contains Nonbinding Recommendations 
A good risk assessment should include an examination of all foreseeable risks associated 
with a device.  Even if a general use x-ray imaging device is not specifically indicated for 
pediatric use, it may be foreseeable that the device will be used on pediatric patients.  
Because the risk posed by the device may vary depending on the particular population 
(including different pediatric subgroups across a range of patient sizes), the risk assessment 
for x-ray imaging devices indicated for pediatric patients (and general use devices for which 
considerable pediatric use is anticipated) should  include the additional hazards and means of 
mitigation associated with all patient populations on whom the device may be used. Your 
risk assessment should include a consideration of applicable critical factors outlined in 
FDAs guidance document entitled Premarket Assessment of Pediatric Medical Devices: 
Guidance for Industry and Food and Drug Administration Staff.29 If the results of the risk 
assessment demonstrate special features or labeling are not necessary to address pediatric 
use, then the premarket 510(k) submission should include that justification. 
 
When developing features or user instructions aimed at reducing radiation exposure to 
pediatric patients, the balance of radiation exposure and image quality for the desired clinical 
task should be considered. While the clinician has the responsibility to determine the final 
settings of the device to meet image quality requirements, manufacturers have a 
responsibility to provide appropriate guidance.   
 
An exam with poor image quality could result in a missed diagnosis or in a repeated exam 
(involving additional radiation exposure to the patient). An exam with a higher than 
necessary radiation exposure provides a level of image quality that is not needed for the 
clinical task as it does not contribute to the clinical purpose of the exam. Examples of 
hazardous situations that could result in unnecessary radiation exposure or poor image 
quality specific to pediatric patients include the following:  
 
  Use of adult settings or protocols instead of appropriate pediatric settings or 
protocols;  
  Design features that do not allow proper positioning of pediatric patients (e.g., a deep 
patient cradle interfering with lateral x-rays of a small patient); 
  Automatic controls that are not calibrated for pediatric patients; and 
  Absence of safety features to prevent radiation exposure outside the anatomy of 
interest when the patient falls outside the typical adult size range.  
 
The above examples are not a comprehensive list. Consultation during the design phase with 
professionals who are knowledgeable regarding pediatric imaging may help identify other 
risks and situations specific to pediatric use of your x-ray imaging device. 
 
VII. Pediatric Device Features  
 
                                                           
29 
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM08
9742.pdf. 
  9  Contains Nonbinding Recommendations 
Based on the results of the risk assessment for the x-ray imaging device, manufacturers 
should include in the 510(k) any particular design features to address pediatric use as risk 
mitigations. The device description should describe those features specifically included to 
allow for imaging of smaller-size and pediatric patients, and these features should also be 
summarized in the Pediatric Summary section of the labeling (see Section XI.A). The Agency 
recommends consultation with knowledgeable pediatric imaging specialists (physicians, 
physicists, and technologists) and human factors specialists30 during the design phase to 
ensure that the device is suitable for pediatric use.  
 
Examples of pediatric use features to consider for x-ray imaging devices are: 
 
  Automatic exposure control (AEC) designed and tested or evaluated, as appropriate, 
for a broad range of patient sizes, including pediatric; 
  Pediatric protocols or pre-set control settings (which clearly specify the intended size 
range) and labeling that consider the balance of radiation exposure and image 
quality;31 
  Display and recording of patient dose or dose index and ability to record other patient 
information, e.g., age, height, weight and patient body part thickness (either manual 
entry or automatic calculation);32 while this recommendation also applies to adult 
imaging, it is especially important to include for pediatric imaging so estimates of 
patient-specific dose can be made reliably without assuming a "typical" or "standard" 
patient size, which are often based on adults; and 
  Software interface features that guide the end user to important pediatric use issues 
(e.g., interactive software pop-ups that remind users of special pediatric issues when 
setting up the image acquisition). 
 
All of the features listed above may not be appropriate for every device. For example, a CT 
scanner will likely have a more sophisticated software interface and capabilities for pre-
programmed protocols than a general radiography or dental imaging device. Other design 
considerations may be specific to the type of x-ray imaging equipment; for an example of 
device-specific considerations, see the white paper by the Medical Imaging Technology 
Alliance (MITA) and Image Gently which discusses design considerations relevant to 
interventional x-ray equipment.33 Relevant pediatric imaging design features may also be 
                                                           
30See the FDA guidance entitled Applying Human Factors and Usability Engineering to Medical Devices 
(http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm259760.pdf ) 
and the standards AAMI /ANSI HE75:2009 (R2013), Human factors engineering - Design of medical  
Devices and ANSI/AAMI/IEC 62366:2007 (R2013), Medical devices  Application of usability engineering to 
medical devices.  
31 While full protocols with technique factors (e.g., tube current, tube voltage, etc.) may be appropriate for full 
x-ray systems, it may be challenging for a component part or accessory device to provide this information. 
However, alternative information may be appropriate. For example, information about IEC exposure index 
ranges may be appropriate for a detector-only device. 
32Appendix, Table 1 entry "dose measurement, display, and documentation" includes relevant dose metrics and 
FDA-recognized standards for different modalities.  
33Essential Questions for Consideration in the Design of Interventional X-ray Equipment Intended for Pediatric 
Use, Image Gently and the MITA Interventional Fluoroscopy Working Group (IWG), published January 2015.  
 
  10  Contains Nonbinding Recommendations 
addressed in device-specific FDA guidance and device-specific FDA-recognized consensus 
standards.34 
VIII.  Protocols  
 
Pediatric-appropriate protocols for common procedures appropriately adjusted for the 
patient's size and weight should be available for all complete x-ray imaging systems for 
which considerable pediatric application is anticipated.  Ideally, special hardware and 
software design issues that affect safety and effectiveness of the device for pediatric use 
should be addressed in the design phase. For example, if use of automatic exposure control is 
recommended on pediatric patients, this feature should be designed for pediatric patients and 
calibrated using methods appropriate for the pediatric population. 
 
The term "protocol" as used in this guidance includes, but is not limited to, a full set of any 
programmed technical factors, control functions and settings, including image processing 
settings, designed to optimize the image acquisition and display. In some cases (e.g., general 
radiography, dental radiography), these protocols may simply consist of instructions (e.g., 
exposure chart) on how to appropriately configure the equipment and adjust parameters for 
the patient weight or thickness, body habitus, and clinical anatomy.  In other cases (e.g., CT), 
it may be appropriate to pre-program the protocols into software.  
 
A list summarizing the available pre-configured, default pediatric protocols should be made 
available to the end user, either as part of the labeling or in downloadable electronic format 
(see Section XI of this guidance). This list should include the protocol name, brief description 
of exam purpose, anatomical region, intended size of patient, and the acquisition parameters 
used as starting points. As discussed in the following section, representative dose information 
(applicable to pediatrics) associated with each protocol should also be provided. 
 
Component parts and accessories to x-ray imaging devices (e.g., detector-only devices) are 
unlikely to fully control all parameters that make up a complete imaging protocol for 
pediatric or adult patients. For these device types, providing some protocol-related 
information may still be appropriate. For example, for a detector-only system, recommended 
detector exposure indices for different types of exams and patient subgroups may be 
adequate instead of technique factors and dosimetric information. 
 
For previously 510(k) cleared x-ray imaging devices, optimization of imaging parameters 
and provision of pediatric-specific protocols by manufacturers solely at the request of end 
users generally does not by itself necessitate submission of a new 510(k) submission. 
                                                           
34 See Appendix B. For example, the current editions of device-specific International Electrotechnical 
Commission (IEC) performance standards, such as IEC 60601-2-43 and IEC 60601-2-54 contain requirements 
for equipment specified for pediatric applications, such as removable anti-scatter grids. Since the FDA public 
meetings in 2010 and 2012, the international standards community has continued to add to the pediatric design 
features included in the device-specific performance standards for x-ray imaging devices.  
  11  Contains Nonbinding Recommendations 
IX.  Laboratory Image Quality and Dose Assessment 
 
Performance of the x-ray imaging device should be assessed over the entire range of patient 
sizes for which the device is indicated.  Because many x-ray imaging devices with general 
indications will experience significant use in pediatric populations, the entire range of patient 
sizes should include neonates through adults.  The range of settings and conditions used for 
testing should represent the routine clinical use of the system (e.g., clinically-relevant 
radiation doses should be used).  Appendix B provides relevant tests and applicable standards 
commonly used to evaluate the performance of x-ray imaging devices.  While Appendix B is 
intended to be as inclusive as possible; not every test listed maybe appropriate for your 
device.  If a device-specific FDA guidance document exists, please consult that guidance 
document for the recommended testing.    
 
The image quality and radiation dose depends on the x-ray path length, so testing should 
address a range of representative path lengths and should be included in the 510(k) 
submission. The appropriate choice of patient sizes will depend on the indications for use of 
your device or device feature and the imaging physics of the specific device functions being 
evaluated.  A devices 510(k) submission should include the rationale for selecting the 
patient sizes used in your testing.  For example, for an abdominal CT protocol that employs 
AEC, it may be appropriate to assess image quality and radiation dose for each sized protocol 
provided; for an interventional x-ray imaging device, measuring air kerma with 10cm and 
20cm PMMA phantoms may be sufficient for pediatric use. When selecting phantoms 
representative of the intended patient population, FDA recommends that manufacturers 
choose phantoms that are capable of replicating the range of representative of the intended 
range of patient size/diameter, rather than selecting phantom distribution based on age. 
 
In cases where the performance of a device or device feature based on patient size is well 
understood (e.g., slice sensitivity profile (SSP), modulation transfer function (MTF), 
uniformity, CT number accuracy), the performance for the largest and the smallest patient 
sizes may be sufficient to demonstrate performance of the device across all patient sizes. In 
these instances, data on intermediate size patients may be extrapolated35.  However, when the 
effect of patient size on the performance of a particular device is less well understood, or the 
device is known to behave non-linearly based on patient size (e.g., iterative reconstruction 
algorithms, AEC, automatic brightness control, tests of temporal resolution), it is more 
appropriate to demonstrate the performance of your device across a larger number of patient 
sizes.  
 
The 510(k) submission should include: 
 
                                                           
35 For an extended discussion of cases where data obtained for adult and adult-sized patients may be 
extrapolated to obtain information applicable to pediatric populations, refer to FDAs guidance Leveraging 
Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices: Guidance for Industry and Food 
and Drug Administration Staff 
(https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm444591
.pdf). While the scope of that guidance is specific to clinical study data extrapolation, some of the concepts may 
be applicable to non-clinical bench testing or sample clinical image data. 
  12  Contains Nonbinding Recommendations 
  A summary of the tests conducted, the methods used, and the test results.  The 
description of the test method should include the system settings (e.g., exposure 
settings such as tube voltage, tube current, and use of AEC) as well as a description of 
the phantoms used and the appropriateness of the phantoms. When reporting dose in 
CT, for example, you may indicate the corresponding phantom with which the 
measurement was acquired (e.g., CTDIvol (32 cm). FDA encourages the standardized 
development, manufacturer implementation, and physician use of Size Specific Dose 
Estimation (SSDE) for estimates of patient dose which more accurately represent the 
dose received by patients of varying sizes (including pediatric populations). If a test 
method has been described fully in the literature and was followed completely, a 
reference may be sufficient.  
  The test conditions used for the assessment and why the selected test conditions are 
sufficient to demonstrate the performance of your device over the entire range of 
patient sizes for which your device is indicated.   
  The measurement uncertainty, the trade name, characteristics, and accuracy of the 
measuring instruments used for performing quantitative tests, if applicable. 
 
In some cases, a manufacturer may have previously demonstrated device performance for 
adult-sized patients. In order to demonstrate the performance of the device for the full range 
of indicated patient sizes in a subsequent premarket submission, it would typically be 
appropriate to amend this data with a new examination of device performance for smaller 
sized patients. 
X.  Clinical Image Quality Assessment  
 
FDA encourages the use of laboratory testing methods to ensure the device is appropriately 
designed for imaging children due to the Agencys concerns with imaging pediatric patients 
with devices and the potential risks of exposing this population to medically unnecessary 
radiation exposure. Clinical images of pediatric patients will only be requested when 
laboratory testing is insufficient to demonstrate substantial equivalence and when 
extrapolation of the necessary data from adult images is not sufficient. If any images are 
provided to the Agency, they should be accompanied by corresponding dose information, 
exposure settings, and clinical information if available (e.g., type of exam, age, size, and sex 
of patient, and clinical indications).  
 
For more information on the appropriate protections for pediatric populations, see FDAs 
guidance entitled Premarket Assessment of Pediatric Medical Devices.36 For questions 
regarding the need for images of pediatric patients, sponsors are encouraged to request a pre-
submission meeting prior to 510(k) submission.  For information on how to submit a pre-
submission, see FDAs guidance entitled Requests for Feedback on Medical Device 
                                                           
36 https://www.fda.gov/RegulatoryInformation/Guidances/ucm089740.htm. 
 
  13  Contains Nonbinding Recommendations 
Submissions: The Pre-Submission Program and Meetings with Food and Drug 
Administration Staff.37  
XI.  Labeling 
 
In addition to information describing the general operation of the device, the user manual 
should contain the following information specific to pediatric use. These labeling 
recommendations to address pediatric use of x-ray imaging devices are intended to be 
supplemental to other labeling recommendations and requirements and not intended to be all 
inclusive of the labeling information expected to be found on an x-ray imaging device.  For a 
more detailed discussion of how the basic elements of labeling may be addressed for 
pediatric populations, please also refer to Section IX of FDAs guidance entitled Premarket 
Assessment of Pediatric Medical Devices.38. 
A.  Pediatric Summary Section 
 
The labeling for end users should include a summary section (see Appendix A) addressing the 
specific features and labeling information (B though F below) for pediatric use of the x-ray 
imaging device. This information is recommended both for devices indicated for pediatric 
use and for general use devices that may be used on pediatric patients. 
 
In order to emphasize the importance of safe device operation when imaging pediatric 
patients, the following caution statement should be included in the pediatric summary 
section: Use special care when imaging patients outside the typical adult size range.39  
 
FDA believes that this statement and general references for pediatric imaging are appropriate 
to include in the labeling of all devices that may be used on pediatric populations, including 
devices with general indications or devices with specific pediatric indications and design 
features. (See Section VI Risk Assessment for more information.) 
B.  Contraindications, Warnings, and Precautions 
 
Contraindications, warnings, and precautions for devices indicated for pediatric populations, 
or general use devices for which considerable pediatric appliacation is anticipated, should 
clearly address the potential risks and their association with the age, size, and condition of 
the pediatric subject and alert the user to specific hazards associated with the use of the 
device in the target population.40 The contraindications, warnings, and precautions should 
                                                           
37 
https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm311176.
pdf. 
38 https://www.fda.gov/RegulatoryInformation/Guidances/ucm089740.htm. 
39 See the sample Pediatric Summary in Appendix A for an example of a full caution paragraph which includes 
this language. 
40 See FDAs guidance entitled "Premarket Assessment of Pediatric Medical Devices; 
(http://www.fda.gov/RegulatoryInformation/Guidances/ucm089740.htm). 
  14  Contains Nonbinding Recommendations 
address the risks specific to pediatric use that were identified during the risk assessment.  If 
warnings and contraindications apply to some but not all pediatric subpopulations, the 
specific applicable subpopulations should be specified. 
 
For devices where the risk of use in pediatric patients or certain pediatric subpopulations 
clearly outweighs possible benefits based on known hazards, we recommend that you include 
a contraindication for use in pediatric patients or pediatric subpopulations. 
C.  Device Description 
 
The device description should include a list of the hardware and software features designed 
specifically for pediatric use. When different options are available for purchase, the labeling 
should describe the various options recommended for use in pediatric subgroups and, when 
feasible, present these options in tabular form by age, weight, or other appropriate criteria.  
 
D.  Instructions for Use 
 
Instructions for how to properly configure the device for pediatric use (and how this may 
differ from adult use) should be provided.  
 
The instructions for use should address radiation dose reduction strategies for pediatric 
patients. All user-configurable imaging parameters should be clearly explained, including 
their impact on patient dose. Combinations of certain parameters that can provide for optimal 
image quality/minimal dose under unusual circumstances (i.e., a difficult or obese patient) 
may be suggested but should be clearly indicated as such. Screenshots of the user interface 
software controls should be provided in the labeling, explaining how different parameters 
affect dose and image quality, particularly for pediatric patients. To mitigate the risk of user 
error, the following should be considered: 
 
  User's manuals in downloadable electronic form with easily searchable interfaces, in 
addition to paper copies; and   
  Leave-behinds/just-in-time educational material such as checklists that include any 
special pediatric issues during pre-acquisition, acquisition, and post-acquisition 
steps41. 
  
Instructions should consider the likely educational background of the end-user; for example, 
equipment likely to be used by professionals other than radiologists or radiologic 
technologists (e.g., dental x-ray or devices designed for cardiac imaging) should include 
information targeted at the appropriate professional groups (e.g., dentists, cardiologists).   
   
                                                           
41An example is the Image Gently/FDA Digital Radiography Safety Checklist 
(http://www.imagegently.org/Portals/6/Procedures/Attachment%20D.CR.DR%20%20checklist.pdf). FDA 
strongly encourages the inclusion of or reference to educational materials related to radiation protection for 
children in x-ray imaging procedures. 
  15  Contains Nonbinding Recommendations 
E.  Quality Control Testing Recommendations 
 
Quality control testing recommendations should include any tests (acceptance testing, annual 
and continuous testing) that ensure the device functions properly across the entire range of 
patient sizes in which the device may be used. 
 
F.  Additional Information 
 
The end-user documentation should include a means to obtain additional information 
regarding the unique operating principles of the device pertaining to pediatric use.  
 
A summary of the physical laboratory tests (See Section IX of this guidance) characterizing 
the performance of the device for pediatric use should be provided.  Users can then employ 
this information in their evaluation of the importance of any tradeoffs between different 
characteristics of imaging performance.  
  
A summary of pediatric protocols (brief description of purpose, acquisition parameters, and 
intended size of patient) should be provided in a separate section of the manual or in a 
downloadable electronic format. Dose information for each protocol should be included with 
the protocol and displayed by the software, where appropriate. Appendix B, Table 1 entry 
"dose measurement, display, and documentation" includes relevant dose metrics and FDA-
recognized standards for different modalities.   
 
If literature is used in support of particular pediatric design features and protocols, a 
summary should be available to users (e.g., table with references and pediatric use topics or 
applications and equipment settings covered in each).  
 
XII. Training and Testing Materials for Users and 
Manufacturers' Personnel 
 
A training program emphasizing production of acceptable quality images at an optimized 
radiation dose for the devices entire patient population should be made available to the 
clinical end user.42 The user's manual may be considered part of this training program.  
 
This training program should emphasize equipment-specific training and the optimal use of 
all built-in dose reduction and image quality improvement features.43  It should explain 
clearly how to use the specific features of the equipment in all populations for which the 
device may be used. Training should be accessible, practical, and targeted at all different 
                                                           
42A model for such a training program for ultrasound devices (not covered by this guidance) is: Medical 
Ultrasound Safety, 2nd ed. (2009) published by the American Institute of Ultrasound in Medicine. 
43Examples of training materials emphasizing pediatric dose reduction are available at the Image Gently 
Alliance website (http://www.imagegently.org). 
  16  Contains Nonbinding Recommendations 
types of end users. If testing questions accompany training sessions, they should address an 
understanding of pediatric use issues (e.g., dose saving features for children). In order to 
facilitate continuous learning, a DVD that includes the content of any in-person training 
sessions could be provided to the facility or made available in another format (e.g., as online 
modules). 
 
The 510(k) submission should include a summary-level description of the training materials 
for the device. The description should point out any pediatric-specific topics covered. 
 
 
  17  Contains Nonbinding Recommendations 
Appendix A: Pediatric Summary Section for Instructions 
for Use 
 
The following is an example of a pediatric summary section for inclusion in the instructions 
for use for any x-ray imaging device for which considerable pediatric appliacation is 
anticipated (both devices indicated for pediatric populations and general use x-ray devices 
not contraindicated for pediatric populations). For x-ray imaging devices without specific 
design features or labeling information, FDA recommends including the Introduction and 
Section A of the below summary in the instructions for use. For x-ray imaging devices with 
specific design features and labeling information to address pediatric use, the entire example 
is applicable (i.e., Introduction, Section A, and Section B).   
 
Manufacturers should adapt the language below as appropriate for their device. For general 
information on radiation safety, FDA encourages device manufacturers to use available 
resources developed by national and international organizations rather than creating new 
material; literature developed by imaging and radiation protection experts is available for all 
of the different modalities covered by this guidance. FDA also encourages manufacturers to 
consider how their device can be better configured for pediatric use, and to provide that more 
specific information to the end user.  
 
Example follows 
Pediatric Use: Summary 
 
Introduction: Special care should be exercised when imaging patients outside the typical 
adult size range, especially smaller pediatric patients whose size does not overlap the 
adult size range (e.g., patients less than 50 kg (110 lb) in weight and 150 cm (59 in) in 
height,measurements, which approximately correspond to that of an average 12 year old 
or a 5th percentile U.S. adult female.44) 
 
Exposure to ionizing radiation is of particular concern in pediatric patients because: 1) for 
certain organs and tumor types, younger patients are more radiosensitive than adults (i.e., 
the cancer risk per unit dose of ionizing radiation is higher for younger patients); 2) use 
of equipment and exposure settings designed for adults of average size can result in 
excessive and unnecessary radiation exposure of smaller patients; and 3) younger patients 
have a longer expected lifetime over which the effects of radiation exposure may 
manifest as cancer. 
 
To help reduce the risk of excessive radiation exposure, you should follow the ALARA 
(As Low As Reasonably Achievable) principle and seek to reduce radiation dose to only 
the amount necessary to obtain images that are adequate clinically. 
 
                                                           
44McDowell, M.A., C.D. Fryar, C.L. Ogden, and K. M. Flegal. 2008. Anthropomorphic Reference Data for 
Children and Adults, United States, 2003-2006. National Health Statistics Reports, 10, 1-48.  
  18  Contains Nonbinding Recommendations 
A. References for pediatric dose optimization: The following resources provide 
information about pediatric imaging radiation safety and/or radiation safety for <insert 
your device modality, e.g., computed tomography, fluoroscopy, general radiography, 
dental radiography> devices: 
<Insert references appropriate to your device>45  
 
B. Device specific features and instructions: The <insert your device name> provides 
the following specific design features and instructions that enable safer use of our device 
with pediatric patients:46 
<insert design features, noting whether they are standard or extra options> 
<insert references to labeling, e.g., protocols, dosimetry information, safe use checklists, 
summary of any testing to evaluate pediatric use> 
 
Design feature important to pediatric imaging47  Page number 
reference in 
Instructions for use 
Protocols or exposure indices  p.  
Removable grid  p.  
Filter  p. 
Variable focal spot size  p. 
Post-processing application   p.  
Reconstruction algorithm  p.  
Automatic Exposure Control  p.  
Etc.   
 
Testing information  Page number 
reference in 
Instructions for use 
Estimated patient dosimetry covering pediatric size ranges  p.  
Image quality assessment (especially to support any pediatric  p.  
performance specifications; may be phantom-based) 
Quality Control instructions including tests to ensure proper  p.  
operation across a broad patient size range 
                                                           
45FDAs website provides radiation safety information references from a variety of groups including the Image 
Gently Alliance: Pediatric X-ray Imaging (http://www.fda.gov/Radiation-
EmittingProducts/RadiationEmittingProductsandProcedures/ucm298899.htm; and Medical X-ray Imaging 
(http://www.fda.gov/Radiation-
EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/MedicalX-Rays/default.htm).  In 
addition, FDAs Pediatric X-ray Imaging Website (https://www.fda.gov/radiation-
emittingproducts/radiationemittingproductsandprocedures/medicalimaging/ucm298899.htm) contains links to 
device-specific pages on Computed Tomography, Fluoroscopy, and Dental Cone-beam Computed Tomography.  
46See Section VII (Pediatic Device Features) for examples. 
47This list of examples is not meant to be exhaustive and it is not appropriate for every device. Some of the 
features you choose to list may not be limited for use on pediatric patients, but may be especially important for 
safe pediatric imaging (e.g., Automatic Exposure Control). 
  19  Contains Nonbinding Recommendations 
Appendix B: General Laboratory Image Quality and Dose 
Assessment, Tests and Standards 
 
This Appendix lists common laboratory tests and the applicable standard for each modality.  
This list is included for reference and is not intended to be exhaustive. The tests listed in this 
Appendix focus on ensuring the imaging device is capable of producing acceptable quality 
images at a reasonable dose. The information may also be included in device-specific 
guidance, which should also be consulted. Inclusion of this list does not imply that all of 
these standards must be followed for every device or that every applicable test and associated 
standard has been listed. For additional standards applicable to specific devices, please refer 
to FDAs Recognized Consensus Standards Database.48 
  
The guidance entitled Recognition and Use of Consensus Standards49 describes how the 
agency will use information on conformance with recognized standards to satisfy premarket 
review requirements. In the case of 510(k)s, information on conformance with recognized 
standards may help establish the substantial equivalence of a new device to a legally 
marketed predicate in the areas covered by the standards. If a 510(k) contains declarations of 
conformity (and the standard to which conformance is claimed includes performance limits 
or acceptance criteria), this will, in most cases, eliminate the need for FDA to review the 
actual test data for those aspects of the device addressed by the standards. Instead of 
following a recognized standard, a firm may choose to submit alternative equivalent 
information demonstrating safety and effectiveness. 
 
The list below focuses on test methods, but the Appendix also includes the performance and 
safety standards for each modality: computed tomography (International Electrotechnical 
Commission (IEC) 60601-2-4450); radiography and fluoroscopy (IEC 60601-2-5451); 
interventional fluoroscopy (IEC 60601-2-4352); dental extra-oral X-ray equipment (IEC 
60601-2-6353); and  dental intra-oral X-ray equipment (IEC 60601-2-6554). Some of these 
standards include features and labeling requirements which are specifically relevant to 
pediatric imaging, while others have feature and labeling requirements which are relevant to 
all sizes of patients (including smaller-sized adult and pediatric patients). For example, IEC 
62985 (Methods for calculating Size Specific Dose Estimate (SSDE) on Computed 
Tomography) describes a method of determining patient dose, scaled from CTDI , which 
vol
provides a more accurate representation of the dose to patients across a wide range of sizes 
                                                           
48http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm 
49http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077274.htm 
50IEC 60601-2-44 Medical electrical equipment  Part 2-44: Particular requirements for the basic safety and 
essential performance of X-ray equipment for computed tomography 
51 IEC 60601-2-54 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and 
essential performance of X-ray 
52 IEC 60601-2-43  Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and 
essential performance of X-ray equipment for interventional procedures 
53 IEC 60601-2-63 Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and 
essential performance of dental extra-oral X-ray equipment 
54 IEC 60601-2-65 Medical electrical equipment  Part 2-65: Particular requirements for the basic safety and 
essential performance of dental intra-oral X-ray equipment 
  20  Contains Nonbinding Recommendations 
(including pediatric and small adult patients). Other standards address issues specific to the 
safety of pediatric patients; for example, as of early 2017 the IEC standards 60601-2-54 and 
IEC 60601-2-43 are being updated to include some of the issues addressed in the Medical 
Imaging & Technology Alliance (MITA) and Image Gently white paper Essential Questions 
for Consideration in the Design of Interventional X-ray Equipment Intended for Pediatric 
Use. FDA continues to work with and encourage standards development organizations to 
address modality-specific features and concerns within their performance and safety 
standards.  
  21  Contains Nonbinding Recommendations 
Table 1. Physical Laboratory Tests and Applicable Standards 
Test and brief description  Modality  Relevant standard or more 
detailed instructions 
Sensitometric Response: The  General radiography  IEC 62220-1-1Medical electrical 
output digital signal value versus the  (excludes dynamic  equipment- Characteristics of 
radiation exposure curve provides  imaging/fluoroscopy and CT)  digital x-ray imaging devices- Part 
the sensitometric response of the  1: Determination of the detective 
image acquisition system.  quantum efficiency Detectors used 
in radiographic imaging 
Dynamic imaging x-ray  IEC 62220-1-3  
devices (e.g., fluoroscopic or  Medical electrical equipment - 
cardiac imaging)  Characteristics of digital X-ray 
imaging devices - Part 1-3: 
Determination of the detective 
quantum efficiency - Detectors used 
in dynamic imaging 
Modulation Transfer Function  CT  IEC 61223-3-5 Evaluation and 
(MTF): Provides a quantitative  routine testing in medical imaging 
measure of the spatial resolution  departmentsPart 3-5: Acceptance 
properties of the image acquisition  testsImaging performance of 
system.  computed tomography X-ray 
equipment  
General radiography  IEC 62220-1-1 Medical electrical 
(excludes dynamic  equipment- Characteristics of 
imaging/fluoroscopy and CT)  digital x-ray imaging devices- Part 
1: Determination of the detective 
quantum efficiency  Detectors used 
in radiographic imaging 
Dynamic imaging x-ray  IEC 62220-1-3  
devices (e.g., fluoroscopic or  Medical electrical equipment - 
cardiac imaging)  Characteristics of digital X-ray 
imaging devices - Part 1-3: 
Determination of the detective 
quantum efficiency - Detectors used 
in dynamic imaging 
Noise Power Spectrum (NPS): As  General radiography  IEC 62220-1-1 Medical electrical 
a function of spatial frequency and  (excludes dynamic  equipment- Characteristics of 
exposure level, this test provides a  imaging/fluoroscopy and CT)  digital x-ray imaging devices- Part 
quantitative measure of the noise  1: Determination of the detective 
properties of the image acquisition  quantum efficiency  Detectors used 
system.  in radiographic imaging 
Dynamic imaging x-ray  IEC 62220-1-3 
devices (e.g., fluoroscopic or  Medical electrical equipment - 
cardiac imaging)  Characteristics of digital X-ray 
imaging devices - Part 1-3: 
Determination of the detective 
quantum efficiency - Detectors used 
in dynamic imaging 
Detective Quantum Efficiency  General radiography  IEC 62220-1-1 Medical electrical 
(DQE): This test provides a  (excludes dynamic  equipment- Characteristics of 
quantitative measure of the  imaging/fluoroscopy and CT)  digital x-ray imaging devices- Part 
efficiency of signal-to-noise ratio  1: Determination of the detective 
(SNR) transfer of the image  quantum efficiency  Detectors used 
acquisition system. This measure is  in radiographic imaging 
  22  Contains Nonbinding Recommendations 
obtained by calculating the detective  Dynamic imaging x-ray  IEC 62220-1-3 
quantum efficiency (DQE) as a  devices (e.g., fluoroscopic or  Medical electrical equipment - 
function of spatial frequency. SNR  cardiac imaging)  Characteristics of digital X-ray 
analysis should be performed using  imaging devices - Part 1-3: 
exposure levels covering the range  Determination of the detective 
normally encountered using your  quantum efficiency - Detectors used 
system to provide the dynamic  in dynamic imaging 
range of the system. 
Image Erasure and Fading: For  General   For testing recommendations 
systems using a delayed readout of  radiography/fluoroscopy  appropriate for radiographic and 
image data, such as a  fluoroscopic systems, please see 
photostimulable phosphor, tests  Section VI Nonclinical 
should include image decay as a  Considerations of the guidance 
function of time and temperature  entitled Guidance for the 
and signal retention as a function of  Submission of 510(k)s for Solid 
the number of erasures and  State X-ray Imaging Devices55 
exposures. 
Repeated Exposure test for  General radiography  IEC 62220-1-1 Medical electrical 
ghosting: Tests for quantitatively  equipment- Characteristics of 
assessing residual images/ghosts are  digital x-ray imaging devices- Part 
described in IEC standards as "lag  1-1: Determination of the detective 
effect" tests.  quantum efficiency  Detectors used 
in radiographic imaging 
Dynamic imaging x-ray  IEC 62220-1-3 Medical electrical 
devices (e.g., fluoroscopic or  equipment - Characteristics of 
cardiac imaging)  digital X-ray imaging devices - Part 
1-3: Determination of the detective 
quantum efficiency - Detectors used 
in dynamic imaging 
Automatic exposure control  CT: 60601-2-44 specifies that  IEC 60601-2-44 Medical electrical 
(AEC) performance: A  CT scanners provide an AEC  equipment  Part 2-44: Particular 
demonstration of the degree of  feature,  61223-3-5includes a  requirements for the basic safety 
control intended with respect to tube  sample test of AEC  and essential performance of X-ray 
current modulation on non-uniform  performance as an informative  equipment for computed 
phantoms or with respect to  annex  tomography;  
temporal gating should be   
performed for a range of exam  and 
conditions (phantom sizes or time   
sequences).  IEC 61223-3-5  Evaluation and 
routine testing in medical imaging 
departmentsPart 3-5: Acceptance 
testsImaging performance of 
computed tomography X-ray 
equipment 
Radiography and fluoroscopy   The following standard also applies 
to interventional fluoroscopy (with 
exceptions and additions noted in 
IEC 60601-2-43): 
IEC 60601-2-54 Medical electrical 
equipment - Part 2-54: Particular 
requirements for the basic safety 
                                                           
55http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073
781.pdf 
 
  23  Contains Nonbinding Recommendations 
and essential performance of X-ray 
equipment for radiography and 
radioscopy56 
Dose or exposure index  CT: Dose indices based on  IEC 60601-2-44 Medical electrical 
measurement, display, automatic  Computed Tomography Dose  equipment  Part 2-44: Particular 
reporting of values, and  Index 100 (CTDI ) and  requirements for the basic safety 
100
documentation  radiation dose structured  and essential performance of X-ray 
reporting standards  equipment for computed 
tomography;  
CT: Dose estimates scaled to  IEC 62985 Methods for calculating 
a range of patient sizes,  Size Specific Dose Estimate (SSDE) 
including pediatric patients  on Computed Tomography 
Radiography and fluoroscopy:  IEC 60601-2-54  Medical electrical 
defines reference air kerma  equipment - Part 2-54: Particular 
and reference air kerma rate  requirements for the basic safety 
and essential performance of X-ray 
equipment for radiography and 
radioscopy 
Interventional fluoroscopy:  IEC 60601-2-43  Medical electrical 
defines reference air kerma,  equipment - Part 2-43: Particular 
reference air kerma rate, dose- requirements for the basic safety 
area product; specifies range  and essential performance of X-ray 
of operating conditions for  equipment for interventional 
dose measurements; defines  procedures 
skin dose as air kerma for   
display purposes 
Exposure index standard for  IEC 62494-1 Medical electrical 
general radiography   equipment - Exposure index of 
digital X-ray imaging systems - Part 
1: Definitions and requirements for 
general radiography 
Radiation dose structured  IEC 60601-2-54 Medical electrical 
reporting for radiography and  equipment - Part 2-54: Particular 
fluoroscopy  requirements for the basic safety 
and essential performance of X-ray 
equipment for radiography and 
radioscopy57 
Reproducibility of radiation  IEC 61223-3-4  Evaluation and 
output for dental x-ray devices  routine testing in medical imaging 
departments - Part 3-4: Acceptance 
tests - Imaging performance of 
dental X-ray equipment  
 
and 
 
IEC 60601-2-63 Medical electrical 
equipment - Part 2-63: Particular 
requirements for the basic safety 
                                                           
56Subclause 203.6.3.2.102 of IEC 60601-2-54 does not mention pediatrics specifically but it does specify a 
range of different-sized phantoms (10, 15, 20 cm thickness) for testing of automatic exposure control for direct 
radiography. 
57 Radiation dose structured reporting is included in Amendment 2 of this standard, which is currently being 
updated. 
  24  Contains Nonbinding Recommendations 
and essential performance of dental 
extra-oral X-ray equipment 
 
and 
 
IEC 60601-2-65 Medical electrical 
equipment  Part 2-65: Particular 
requirements for the basic safety 
and essential performance of dental 
intra-oral X-ray equipment 
Modality-specific tests not  Dental x-ray imaging:  IEC 61223-3-4  Evaluation and 
specified in above categories  Line pair resolution; Low  routine testing in medical imaging 
(examples included for reference;  contrast resolution; Image  departments - Part 3-4: Acceptance 
not exhaustive)  homogeneity; Accuracy of x- tests - Imaging performance of 
ray tube voltage and current  dental X-ray equipment 
 
and 
 
IEC 60601-2-63 Medical electrical 
equipment - Part 2-63: Particular 
requirements for the basic safety 
and essential performance of dental 
extra-oral X-ray equipment 
 
and 
 
IEC 60601-2-65 Medical electrical 
equipment  Part 2-65: Particular 
requirements for the basic safety 
and essential performance of dental 
intra-oral X-ray equipment 
CT:  IEC 61223-3-5  Evaluation and 
Sensitivity Profile; Patient- routine testing in medical imaging 
Support Positioning and  departmentsPart 3-5: Acceptance 
Accuracy; Tomographic  testsImaging performance of 
Section Thickness; Noise;  computed tomography X-ray 
Uniformity; Mean CT  equipment;   
Numbers   
and 
 
IEC 60601-2-44 Medical electrical 
equipment  Part 2-44: Particular 
requirements for the basic safety 
and essential performance of X-ray 
equipment for computed 
tomography 
Fluoroscopy and radiography:   IEC 60601-2-54  Medical electrical 
Additional tests are specified  equipment - Part 2-54: Particular 
in the standards on the right  requirements for the basic safety 
(some of these tests are also  and essential performance of X-ray 
included in the FDA  equipment for radiography and 
performance standards).  radioscopy 
 
and 
 
  25  Contains Nonbinding Recommendations 
IEC 60601-2-43  Medical electrical 
equipment - Part 2-43: Particular 
requirements for the basic safety 
and essential performance of X-ray 
equipment for interventional 
procedures 
 
 
  26