On June 14, 2023, FDA issued a guidance titled Content of Premarket Submissions for Device 
Software Functions.1 This final guidance supersedes the Guidance for the Content of Premarket 
Submissions for Software Contained in Medical Devices, issued on May 11, 2005. The final 
guidance issued on June 14, 2023, provides information regarding the recommended 
documentation sponsors should include in premarket submissions for FDAs evaluation of the 
safety and effectiveness of device software functions. In particular, the final guidance includes 
information to help determine a devices Documentation Level (formerly known as Level of 
Concern). The purpose of the Documentation Level is to help identify the minimum amount of 
information that would support a premarket submission that includes device software functions. 
Within the framework of the superseded guidance, display devices intended for diagnostic 
radiology were considered a device with a Minor Level of Concern. Based on the devices risk in 
the context of the devices intended use, as discussed in the final guidance Content of Premarket 
Submissions for Device Software Functions, display devices intended for diagnostic radiology 
should generally address the recommendations for a Basic Documentation Level. The actual 
Documentation Level for your device may vary based on the specifics of your device. For more 
information about the Documentation Level and recommended documentation for a premarket 
submission, sponsors are encouraged to review the guidance Content of Premarket Submissions 
for Device Software Functions. 
1 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-
submissions-device-software-functions.  Contains Nonbinding Recommendations
Display Devices for Diagnostic 
Radiology 
Guidance for Industry and
Food and Drug Administration Staff
Document issued on September 28, 2022.
Document originally issued on October 2, 2017.
This document supersedes the Guidance for Industry and FDA Staff: Display 
Accessories for Full-Field Digital Mammography Systems-Premarket 
Notification (510(k)) Submissions issued May 30, 2008.
For questions about this document, contact RadHealth@fda.hhs.gov. 
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health 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-2016-D-0270. 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 email request to CDRH-
Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document number 
1500022 and complete title of the guidance in the request. Contains Nonbinding Recommendations
Table of Contents
I.  Introduction ............................................................................................................................... 1
II.  Background ............................................................................................................................... 2
III. Scope ......................................................................................................................................... 2
IV. Describing Your Device in a 510(k) ......................................................................................... 4
A.  Indications for Use ........................................................................................................ 4
B.  Device Description........................................................................................................ 4
V.  Electrical Safety ........................................................................................................................ 5
VI. Firmware and Software Documentation ................................................................................... 6
VII.  Physical Laboratory Testing ............................................................................................... 7
VIII.  Labeling .............................................................................................................................. 8
Appendix ......................................................................................................................................... 9
A.  Performance Tests ....................................................................................................... 10
B.  Device Modifications .................................................................................................. 11
C.  Device Bundling ......................................................................................................... 11 Contains Nonbinding Recommendations
Display Devices for Diagnostic 
Radiology
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
The FDA is issuing this guidance to assist industry in preparing premarket notification (510(k)) 
submissions for display devices intended for use in diagnostic radiology. 
This guidance is intended to apply to current technologies; however, FDA may request new or 
alternative test methods to fully evaluate the safety and effectiveness of future display 
technologies. In such instances, we recommend that you contact FDA to determine the 
appropriate regulatory pathway and testing for your device prior to submitting a 510(k). Please 
see Section III. Scope for more details on the types of devices covered by this guidance 
document.
For the current edition of the FDA-recognized consensus standards referenced in this document, 
see the FDA Recognized Consensus Standards Database.1 For more information regarding use of 
consensus standards in regulatory submissions, please refer to the FDA guidance titled 
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical 
Devices.2
In general, FDAs guidance documents 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 guidances means that something is suggested or recommended, 
but not required.
1 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
2 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices.
1 Contains Nonbinding Recommendations
II.  Background
This guidance applies to display devices intended for diagnostic radiology as identified in 
Section III. Scope, and currently classified under 21 CFR 892.2050 as class II devices.  
This guidance document provides recommendations for the types of information you should 
provide in your 510(k) submission for display devices intended for diagnostic radiology. This 
information supplements the requirements for a 510(k) submission found in 21 CFR 807 Subpart 
E, as well as recommendations provided in other FDA documents concerning the specific 
content of a 510(k) submission, including FDAs guidance entitled, Format for Traditional and 
Abbreviated 510(k)s3 and FDAs guidance entitled, Refuse to Accept Policy for 510(k)s.4   
This guidance supersedes a previously issued final guidance entitled Display Accessories for 
Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions issued 
on May 30, 2008.
This guidance was revised with minor updates to reflect the issuance of the final rule, Medical 
Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions 
in the 21st Century Cures Act (86 FR 20278).5
III.  Scope
This document recommends what to include in a 510(k) submission for display devices in 
diagnostic radiology as identified by their classification regulation (21 CFR 892.2050) and 
product code (PGY). These devices are classified as class II devices that are intended to be used 
in controlled viewing conditions to display and view digital images for primary image 
interpretation. Display devices for diagnostic radiology may also be referred to as soft-copy 
displays or medical grade monitors. The classification regulation for these devices reads as 
follows:
21 CFR 892.2050 Medical image management and processing system
a)  Identification. A medical image management and processing system is a device that 
provides one or more capabilities relating to the review and digital processing of medical 
images for the purposes of interpretation by a trained practitioner of disease detection, 
diagnosis, or patient management. The software components may provide advanced or 
complex image processing functions for image manipulation, enhancement, or 
quantification that are intended for use in the interpretation and analysis of medical 
images. Advanced image manipulation functions may include image segmentation, 
multimodality image registration, or 3D visualization. Complex quantitative functions 
3 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditional-and-
abbreviated-510ks.
4 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-
510ks.
5 See 86 FR 20278 at https://www.federalregister.gov/documents/2021/04/19/2021-07860/medical-devices-medical-
device-classification-regulations-to-conform-to-medical-software-provisions.
2 Contains Nonbinding Recommendations
may include semi-automated measurements or time-series measurements. 
b)  Classification. Class II (special controls; voluntary standards  Digital Imaging and 
Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) 
Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
Typically, the 510(k) submission for display devices is separate from the 510(k) submissions of 
other image acquisition or management devices (e.g., hardware/software for image acquisition or 
image analysis). However, this guidance may apply when displays intended for diagnostic 
interpretation classified under 892.2050 (product code PGY) are included as part of a 510(k) 
submission along with other software and/or hardware.
This guidance does not apply to real-time displays that are part of the image acquisition device 
classified under other regulations (e.g., the display on a fluoroscopy system classified under 21 
CFR 892.1650 (e.g., product codes JAA, OWB, OXO, QHY, and RCC) or the display on an 
ultrasonic pulsed Doppler imaging system classified under 21 CFR 892.1550 (e.g., product codes 
PSV, IYN, and NCS)). 
This guidance does not apply to medical image hardcopy devices under 21 CFR 892.2040. 
This guidance does not apply to imaging software and software applications. For information on 
these types of devices, please see FDAs guidance entitled Medical Device Data Systems, 
Medical Image Storage Devices, and Medical Image Communications Devices.6
This guidance does not apply to ophthalmic image management systems (product code NFJ) 
classified under 21 CFR 892.2050; medical cathode-ray tube (product code DXJ) classified 
under 21 CFR 870.2450; displays intended for whole-slide imaging and digital surgical or 
anatomical pathology; or displays for non-diagnostic applications in radiology (e.g., displays at 
the image acquisition workstation that are used by the technologist and not intended for 
diagnostic image review). 
This guidance also does not apply to displays in handheld or mobile devices, a certain subset of 
which may be classified under 21 CFR 892.2050 (with product code PGY); for information on 
these types of devices see FDAs guidance entitled Policy for Device Software Functions and 
Mobile Medical Applications.7
Sponsors may wish to submit a pre-submission to the appropriate review Division to receive 
guidance for displays not covered by this guidance. For information on FDAs pre-submission 
process, see FDAs guidance entitled Requests for Feedback and Meetings for Medical Device 
Submissions: The Q-Submission Program.8
6 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-data-
systems-medical-image-storage-devices-and-medical-image-communications-devices.
7 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-device-software-
functions-and-mobile-medical-applications.
8 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-
meetings-medical-device-submissions-q-submission-program.
3 Contains Nonbinding Recommendations
If you are submitting a 510(k) for modification(s) to a cleared display or the same 
modification(s) apply to a number of display models, please refer to Appendices B. and C. for 
further information.
IV.  Describing Your Device in a 510(k)
When submitting a 510(k) for the types of devices described in this guidance, you should 
identify your device by regulation and product code as described in Section III. Scope and 
include the information discussed below. You must provide information to FDA showing how 
your device is substantially equivalent (SE) to a predicate device (sections 513(f)(1) and 513(i) 
of the Federal Food, Drug, and Cosmetic Act (FD&C Act)); 21 CFR 807.87(f)). We recommend 
that your 510(k) include the information described below, if applicable.
A.  Indications for Use
The Indications for Use statement (IFU) should provide a general description of the disease(s) or 
condition(s) that your device will be used to help diagnose and the patient population for which 
the device is intended. The IFU should state whether your device is or is not intended for 
mammography. For instance, if your device is intended for mammography, including full-field 
digital mammography and digital breast tomosynthesis, your IFU should read as follows:
The ________ is indicated for use in displaying radiological images (including full-field 
digital mammography and digital breast tomosynthesis) for review, analysis, and 
diagnosis by trained medical practitioners.
An example IFU if the device is not intended for mammography should read as follows:
The ________ is indicated for use in displaying radiological images for review, analysis, 
and diagnosis by trained medical practitioners. The display is not intended for 
mammography.
You should compare your devices IFU to the IFU of the predicate device, including any specific 
intended uses.  
B.  Device Description
We recommend that you provide a complete description of your device by including the 
information discussed below in your 510(k) submission. The items below should be presented in 
a tabular side-by-side comparison with the predicate device. The 510(k) submission should 
include a discussion of any differences in the technological characteristics between your device 
and the predicate device with additional information necessary to determine whether the 
differences raise new questions regarding the safety or effectiveness of the new device. 
Additional discussion in paragraph form is recommended for novel features. Your device 
description should include information such as the following:
4 Contains Nonbinding Recommendations
 Display Technology: A description of the technological characteristics of the display 
device (e.g., in-plane switching liquid crystal display (LCD) panel with thin-film 
transistor (TFT) active-matrix array with cold cathode fluorescent lamp (CCFL) 
backlight).
 Screen size: A description of the physical size of the viewable area in diagonal and 
aspect ratio.
 Backlight type (transmissive displays only): A description of the backlight type and, if 
substantially different from the predicate device, main properties, including temporal, 
spatial, and spectral characteristics.
 Frame rate and refresh rate: A description of the frame rate and refresh rate.
 Pixel array, pitch, subpixel pattern, and pixel aperture ratio: A description of the 
pixel array including pixel size, pixel pitch, and subpixel pattern (e.g., chevron, red, 
green, blue, and white (RGBW)). 
 Subpixel driving (spatial and temporal dithering): A description that indicates if the 
subpixels are used to improve gray-scale, temporal resolution, or spatial resolution.
 Display Interface: A description of the display interface (e.g., digital visual interface 
(DVI), display port, high-definition multimedia interface (HDMI)). 
 Video bandwidth: A description of the capabilities of the information transfer pipeline 
between the image source and the digital driving levels in all associated components 
including the central processing unit (CPU)/graphics processing unit (GPU), graphics 
card, and display interface.
 User controls: A description of either the on-screen display (OSD) or software available 
for end users that relate to the display image quality (e.g., brightness and contrast 
controls, gamma, white point, power saving options, etc.).
 Ambient light sensing: A description of the ambient light sensing method, 
instrumentation, and software tool description.
 Touch-screen technology: A description of the method, functionality, and any 
calibration or periodical re-tuning requirements.
 Luminance calibration tools: A description of the sensor hardware and associated 
software for performing luminance calibration, and if applicable, details about the user-
level procedures, service-action tolerances, and centralized automatic calibration tools.
 Quality control procedures: A description of the frequency and nature of quality-
control tests to be performed by the user and/or the physicist with associated action 
limits. A detailed quality control manual should be included for regulatory review.
 Software/Firmware: A list with descriptions of any additional firmware or software 
features for image manipulation or analysis and color management (if applicable) not 
covered by any of the above items.
For further detail related to the recommended content of each item above, please refer to 
Appendix A.
V.  Electrical Safety
5 Contains Nonbinding Recommendations
You should evaluate the electrical safety of your device according to one or more of the most 
recent FDA-recognized version of the following consensus standards, or any equivalent method 
being used as an alternative to evaluate electrical safety:
  ANSI/AAMI ES60601-1 Medical electrical equipment: Part 1: General requirements for 
basic safety and essentional performance
For 510(k) submissions for display devices intended for diagnostic radiology, in lieu of 
providing the actual electric safety test reports, you may simply submit a Declaration of 
Conformity to an FDA-recognized consensus standard to indicate that your device has been 
tested for compliance with the appropriate consensus standards. FDA may request to review the 
actual test reports if the IFU, device description, and/or labeling for your device raises concerns 
regarding the electrical safety. The features and design of your device will determine whether 
other consensus standards are appropriate in addition to, or in place of the consensus standards 
provided above. For more information on the use of consensus standards, please refer to section 
514(c)(1)(B) of the FD&C Act and FDAs website on the Standards and Conformity Assessment 
Program.9
VI.  Firmware and Software Documentation
Display devices intended for diagnostic radiology may include firmware and software for the 
following functionalities: 
 Display controls,
 Ambient light sensing,
 Luminance calibration tools, and/or
 Quality-control software.
Your 510(k) submission should include documentation for the software and firmware that you 
have developed for use with your device. The kind of information that we recommend you 
submit in your 510(k) is determined by the level of concern, which is based on the risks 
associated with a potential software failure by your device. If the software/firmware is limited to 
the four functionalities listed above, the level of concern may be considered minor. If your 
device submission introduces or modifies more advanced software features than those features 
listed above, you should consider contacting the relevant branch chief or submitting a Pre-
Submission to request FDAs feedback on whether the software would be a minor, moderate, or 
major level of concern. In most instances, the software documentation may be submitted in your 
510(k) at a minor level of concern. When preparing the software documentation for your 510(k) 
submission and for guidance on what information you should include based on the level of 
concern, please see the following FDA guidance documents:
9 Available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-
and-conformity-assessment-program.
6 Contains Nonbinding Recommendations
 Guidance for the Content of Premarket Submissions for Software Contained in Medical 
Devices;10
 General Principles of Software Validation;11
 Off-the-Shelf Software Use in Medical Devices;12
  Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) 
Software;13 and
  Content of Premarket Submissions for Management of Cybersecurity in Medical 
Devices.14 
 
VII. Physical Laboratory Testing 
We recommend that you provide the following performance testing data with a side-by-side 
comparison of technical performance testing data to the predicate device in your 510(k) 
submission. Table 1 below identifies what tests we recommend you perform in demonstrating 
substantial equivalence to a predicate device based on the IFU of your display device (Table 1 
includes recommendations for both non-mammography and mammography intended uses). 
Please refer to Appendix A. for additional guidance on each test and references for methods and 
procedures for display characterization.
Table 1.  Recommended Physical Laboratory Tests
Recommended for  Recommended for 
Measurements Non-mammography  Mammography 
Display Submissions Display Submissions
a.  Spatial resolution Yes Yes
b.  Pixel defects (maximum counts, allowed 
Yes Yes
defect types, and locations)
c.  Artifacts  Yes Yes
d.  Temporal response Yes (Limited) Yes
e.  Luminance (maximum, minimum, 
Yes Yes
achievable, and recommended)
f.  Conformance to a grayscale-to-
luminance function (e.g., DICOM  Yes  Yes 
GSDF)
10 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-
premarket-submissions-software-contained-medical-devices.
11 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-
software-validation.
12 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/shelf-software-use-
medical-devices.
13 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-
networked-medical-devices-containing-shelf-ots-software.
14 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-
submissions-management-cybersecurity-medical-devices-0.
7 Contains Nonbinding Recommendations
Recommended for  Recommended for 
Measurements Non-mammography  Mammography 
Display Submissions Display Submissions
g.  Luminance at 30 and 45 in diagonal, 
horizontal, and vertical directions at  No Yes
center and four corners
h.  Luminance uniformity or Mura test No Yes
i.  Stability of luminance and chromaticity 
response with temperature and time of  No Yes
operation or on-time
j.  Spatial noise No Yes
k.  Reflection coefficient No Yes
l.  Veiling glare or small-spot contrast No Yes
For color displays, the following measurements should also be reported:
m. Color tracking (primary colors and color 
Yes Yes
gamut)
n.  Gray tracking (gray shades and white 
No Yes
point)
We recommend that you include a brief description of the test method(s) you have used to 
address each performance aspect identified in Table 1 above. If you follow a suggested test 
method, you may cite the method rather than describing it in your 510(k) submission. If you 
modify a suggested test method, you may cite the method, but should provide sufficient 
information to explain the nature of and reason for the modification. We recommend that you 
provide a description of all proprietary measurement systems used for performing quantitative 
tests, including the trade name, characteristics, and accuracy of the measurement tools.
For cases where the new device performs significantly lower than the predicate device on one or 
more of the physical laboratory tests in Table 1, an additional study that further characterizes 
underperforming features of the display may be necessary to demonstrate substantial equivalence 
to a predicate device.
VIII.  Labeling
The following Section is intended to assist you in preparing labeling that satisfies FDAs labeling 
requirements under 21 CFR Part 801.15
A prescription device in compliance with 21 CFR 801.109 is exempt from section 502(f)(1) of 
the FD&C Act that requires adequate directions for use by a lay person. As a prescription device, 
your device must meet the labeling requirements for prescription devices under 21 CFR 801.109, 
including a prescription use statement.
15 Although final labeling is not required for 510(k) clearance, final labeling must comply with the requirements of 
21 CFR Part 801 before a medical device is introduced into interstate commerce. In addition, final labeling for 
prescription medical devices must comply with 21 CFR 801.109. Labeling recommendations in this guidance are 
consistent with the requirements of 21 CFR Part 801.
8 Contains Nonbinding Recommendations
Your 510(k) submission must include proposed labels, labeling, and advertisements in sufficient 
detail to satisfy the requirements of 21 CFR 807.87(e). We recommend that you submit clear and 
concise instructions for use that delineate the technological features of your device and how your 
device is to be used. Instructions should encourage local/institutional training programs designed 
to familiarize users with the features of your device and instruct users on how to use your device 
in a safe and effective manner.
FDA recommends that the labeling for review workstation displays intended for mammography 
include the following statement:
Mammographic images with lossy compression must not be reviewed for primary image 
interpretations. Mammographic images may only be interpreted using an FDA cleared 
display that meets technical specifications reviewed and accepted by FDA.
In addition to meeting any requirements under 21 CFR Part 801, your devices user manual 
should include the following information, as appropriate:
 IFU as stated in your premarket submission;
 Warnings and precautions (and any mitigation measures);
 Overview of the device;
 Principles of operation;
 Directions for use (e.g., display controls and graphical user interface (GUI));
 Technical specifications; 
 Performance specifications (summary of physical laboratory testing); 
 Cleaning information; 
 Hardware/software compatibility requirements;
 Conformity to any voluntary consensus standards; and
 Manufacturers contact information.
In addition, instructions for maintenance of the system performance (quality assurance 
processes) should include:
 A description of personnel authorized to service the system;
 Recommended maintenance schedule; 
 Calibration procedures; and
 A full description of recommended quality assurance testing (with action limits), 
including detailed procedures for performing these tests, if applicable, and the frequency 
of testing. You may use the latest recognized consensus standards version of NEMA XR 
22: Quality Control Manual Template for Manufacturers of Displays and 
Workstations Labeled for Final Interpretation in Full-Field Digital Mammography 
(FFDM) for designing quality assurance tests.
Appendix
9 Contains Nonbinding Recommendations
A.  Performance Tests
The following provides additional details on the individual tests recommended in Section VII. 
Physical Laboratory Testing, along with an explanation of what information should be included 
for each test.
a.  Spatial resolution: Measurements of the transfer of information from the image data to 
the luminance fields at different spatial frequencies of interest typically done by reporting 
the modulation transfer function. Non-isotropic resolution properties should be 
characterized properly by providing two-dimensional measurements or measurements 
along at least two representative axes.
b.  Pixel defects: Measurements (count, types (e.g., sub-pixel or entire pixel, always-on, 
always-off), and locations (map)) of pixel defects. This is typically provided as a 
tolerance limit. Pixel defects can interfere with the visibility of small details in medical 
images.
c.  Artifacts: Evaluate for image artifacts such as ghosting and/or image sticking from 
displaying a fixed test pattern for a period of time.
d.  Temporal response: Measurements of the temporal behavior of the display in responding 
to changes in image values from frame to frame. Since these transitions are typically not 
symmetric, rise and fall time constants are needed to characterize the system. Slow 
displays can alter details and contrast of the image when large image stacks are browsed 
or in video, panning, and zooming modes.
a.  For non-mammography displays, you should measure the rise and fall time 
constants for 595% and 4060% luminance transitions.
b.  For mammography displays, you should measure the rise and fall time constants 
at several (e.g., every 15 levels) grayscale intervals between 0 and 255.
e.  Maximum and minimum luminance (achievable and recommended): Measurements of 
the maximum and minimum luminance that the device outputs as used in the application 
under recommended conditions and the achievable values if the device is set to expand 
the range to the limit.
f.  Conformance to a grayscale-to-luminance function (e.g., DICOM GSDF): 
Measurements of the mapping between image values and the luminance output following 
a target model response for 256 or more levels.
g.  Luminance at 30 and 45 in diagonal, horizontal, and vertical directions at center and 
four corners: Measurements of the luminance response at off-normal viewing related to 
the target model for the luminance response.
h.  Luminance uniformity or Mura test: Measurements of the uniformity of the luminance 
across the display screen.
i.  Stability of luminance and chromaticity responses with temperature and time of 
operation (on-time): Measurements of the change in luminance and chromaticity 
response with temperature and use time.
j.  Spatial noise: Measurements of the spatial noise level as represented by the noise power 
spectrum using an appropriate ratio of camera and display pixels. Spatial noise and 
resolution affect the way images are presented to the viewer and can alter features that 
are relevant to the interpretation process of the physician or radiologist.
10 Contains Nonbinding Recommendations
k.  Reflection coefficients: Measurements of the reflection coefficients of the display device. 
Specular and diffuse reflection coefficients can be used as surrogates for the full 
bidirectional reflection distribution function.
l.  Veiling glare or small-spot contrast: Measurements of the contrast obtained for small 
targets.
m. Color tracking: Chromaticity at different luminance levels of primary colors as indicated 
by the color coordinates in an appropriate units system (e.g., CIE uv) and the color 
gamut enveloped by the primary colors.
n.  Gray tracking: Chromaticity at different luminance levels of gray shades, including the 
white point, as indicated by the color coordinates in an appropriate units system (e.g., 
CIE uv) (see the recognized version of IEC 62536-1 Medical electrical equipment - 
Medical image display systems - Part 1: Evaluation methods, and ISO/CIE 11664-5 
Colorimetry - Part 5: CIE 1976 L*u*v* colour space and u', v' uniform chromaticity 
scale diagram).
For device description as well as testing methods and procedures for display characterization, 
please refer to the following:
 Samei, E., et al., Assessment of display performance for medical imaging systems: 
Executive summary of AAPM TG18 Report. Medical Physics, 2005. 32(4):1205-1225. 
https://doi.org/10.1118/1.1861159. 
 International Electrotechnical Commission IEC 62536-1 Medical electrical equipment - 
Medical image display systems - Part 1: Evaluation methods; and
 International Committee for Display Metrology (ICDM). Information Display 
Measurements Standard (IDMS). http://www.icdm-sid.org.
B.  Device Modifications
We recommend that you refer to FDAs guidance entitled Deciding When to Submit a 510(k) 
for a Change to an Existing Device16 for subsequent models of the same device family that have 
previously received 510(k) clearance. You should perform regression testing and physical 
laboratory testing in conformance with the relevant test consensus standards to verify that the 
changes did not adversely impact image quality and ensure that the device conforms to 
specifications as required under the Quality System Regulation (21 CFR 820.70). For example, 
changes in the graphics driver, power supply, or upgrade in the calibration software are unlikely 
to affect the safety and effectiveness of the device, and thus, such changes are unlikely to require 
a new 510(k) submission under 21 CFR 807.81(a)(3), but sponsors should review the appropriate 
regulations and consensus standards to determine whether a new 510(k) submission is necessary. 
Sponsors should contact the appropriate FDA review Division with any questions about 
modifications made to their devices.
C.  Device Bundling
16 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-
510k-change-existing-device.
11 Contains Nonbinding Recommendations
Often, firms may make the same modification(s) to all of their display models. Instead of 
submitting a separate 510(k) submission for each display model, FDA recommends submitting a 
bundled submission for all impacted display models. Bundling is appropriate for devices that 
present scientific and regulatory issues that can most efficiently be addressed during one 510(k) 
submission review. For more information, please refer to FDAs guidance entitled Bundling 
Multiple Devices or Multiple Indications in a Single Submission.17
17 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bundling-multiple-
devices-or-multiple-indications-single-submission.
12