Contains Nonbinding Recommendations 
Policy Clarification for Certain 
Fluoroscopic Equipment 
Requirements 
Guidance for Industry and Food and 
Drug Administration Staff 
Document issued on May 8, 2019. 
The draft of this document was issued on September 25, 2014. 
For questions about this document, contact the Division of Radiological Health at 301-796-
2121 or Donald Miller at 301-796-3299 or by e-mail at Donald.Miller@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 Division of Dockets 
Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), 
Rockville, MD 20852. Identify all comments with the docket number FDA-2014-D-1344. 
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 1806 to identify the guidance you are requesting.  Contains Nonbinding Recommendations 
Table of Contents 
I.  Introduction ................................................................................................................... 1 
II.  Background ................................................................................................................... 1 
III.  Scope ............................................................................................................................. 2 
IV.  Specific Portions of the Performance Standard that are the Subject of this Guidance .3 Contains Nonbinding Recommendations 
Policy Clarification for Certain 
Fluoroscopic Equipment Requirements
 
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 intends to clarify FDAs interpretation of certain aspects of the 
performance standard requirements in 21 CFR 1020.30 and 1020.32 for fluoroscopic 
equipment. 
For the current edition of the FDA-recognized standard(s) referenced in this document, 
see the FDA Recognized Consensus Standards Database.1
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's 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. 
II.  Background 
In 2005, the Agency amended the federal performance standard for fluoroscopic 
equipment found at 21 CFR 1020.32 to account for changes in the technology and use of 
radiographic and fluoroscopic x-ray systems and to fully utilize the International System 
of Units to describe radiation-related quantities and their units when used in the federal 
performance standard for fluoroscopic equipment found at 21 CFR 1020.32.2
                                                          
1 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. 
2 70 FR 33998, June 10, 2005. 
1  Contains Nonbinding Recommendations 
On March 30-31, 2010, the Agency held a public meeting on Device Improvements to 
Reduce Unnecessary Radiation Exposure from Medical Imaging.3  FDA sought input on 
steps that manufacturers of computed tomography and fluoroscopic devices could take to 
reduce unnecessary radiation exposure to patients, and asked a number of specific 
questions related to equipment features, labeling, premarket submission requirements, 
user training, and quality assurance measures.4  Many of the recommendations FDA 
received at the public meeting focused on incorporating certain features and safeguards, 
to the extent possible, that had been identified in recently amended IEC standards.5
Based on this discussion, it became clear that there are some areas of the federal 
performance standard for fluoroscopic equipment, found at 21 CFR 1020.30 and 21 CFR 
1020.32, that could be further clarified. 
III.  Scope 
The products addressed by this guidance are both devices as defined in section 201(h) 
of the Federal Food, Drug and Cosmetic Act (FD&C Act) and electronic products as 
defined in section 531 of the FD&C Act.  As such, these products are subject to the laws 
and regulations in the FD&C Act and its implementing regulations that apply to devices, 
as well as those applicable to electronic products.  In particular, these products are subject 
to, among other laws and regulations, 21 CFR 892.1650, 1020.30, and 1020.32.  This 
guidance is limited to fluoroscopic x-ray systems, whether stationary or mobile, classified 
as follows: 
21 CFR 892.1650  Image-intensified fluoroscopic x-ray system. 
(a) Identification. An image-intensified fluoroscopic x-ray system is a device 
intended to visualize anatomical structures by converting a pattern of x-
radiation into a visible image through electronic amplification.  This generic 
type of device may include signal analysis and display equipment, patient and 
equipment supports, component parts, and accessories. 
(b) Classification. Class II.  When intended as an accessory to the device 
described in paragraph (a) of this section, the fluoroscopic compression device 
is exempt from the premarket notification procedures in subpart E of part 807 
of this chapter subject to 892.9. 
                                                          
3 Final white paper available at: https://www.fda.gov/radiation-emitting-products/initiative-reduce-
unnecessary-radiation-exposure-medical-imaging/white-paper-initiative-reduce-unnecessary-radiation-
exposure-medical-imaging. 
Public docket available at: 
http://www.regulations.gov/#!docketDetail;dct=FR%252BPR%252BN%252BO%252BSR;rpp=25;po=0;D
=FDA-2010-N-0080. 
4 75 FR 8375, February 24, 2010. 
5 Specifically, IEC, 60601-2-43, Particular requirements for the basic safety and essential performance of 
X-ray equipment for interventional procedures and IEC, 60601-2-54, Particular requirements for the basic 
safety and essential performance of X-ray equipment for radiography and radioscopy. 
2 Contains Nonbinding Recommendations 
The following product codes are currently associated with this regulation and addressed 
by this guidance: 
  JAA  system, x-ray, fluoroscopic, image-intensified 
  OWB  interventional fluoroscopic x-ray system 
  OXO  image-intensified fluoroscopic x-ray system, mobile 
An image-intensified fluoroscopic x-ray system refers to any fluoroscopic x-ray system 
with an image receptor comprised of either an image intensifier or a solid-state x-ray 
imaging device. 
Angiographic x-ray system devices, classified in 21 CFR 892.1600, are not addressed by 
this guidance, as they do not have the capability to perform fluoroscopy. 
IV.  Specific Portions of the Performance Standard that 
are the Subject of this Guidance 
Three aspects of the federal performance standard for fluoroscopic equipment (21 CFR 
1020.32) are described below, with FDAs clarifications:   
  Fluoroscopic Irradiation Time 
21 CFR 1020.32(h)(2) requires that x-ray controls manufactured on or after 
June 10, 2006, provide a display of the fluoroscopic irradiation time at the 
fluoroscopist's working position (fluoroscopic irradiation time is more 
commonly known as fluoroscopy time).  Specific requirements are provided 
at 21 CFR 1020.32(h)(2)(i) and (ii). 
21 CFR 1020.30(b) defines fluoroscopic irradiation time as the cumulative 
duration during an examination or procedure of operator-applied continuous 
pressure to the device, enabling x-ray tube activation in any fluoroscopic mode 
of operation. 
FDA interprets this definition to mean the cumulation of the entire time that the 
fluoroscopy control (typically a pedal) is activated by the operator (operator-
applied continuous pressure).  When defined this way, a single minute of 
continuous pressure on the fluoroscopy control results in a fluoroscopic 
irradiation time of one minute, regardless of whether fluoroscopy is used in a 
pulsed or continuous mode, and, if pulsed, regardless of pulse width and pulse 
rate.  
This interpretation is consistent with statements made by professional 
organizations.  For example, the Society of Interventional Radiology (SIR), in 
its Standards of Practice, defines fluoroscopy time as [t]he total time that 
fluoroscopy is used during an imaging or interventional procedure.  For each 
3 Contains Nonbinding Recommendations 
fluoroscopic series, the fluoroscopic time is measured from the start to the end 
of x-ray production (start of first pulse to the end of the last pulse).6
FDAs interpretation of 21 CFR 1020.30(b) is also consistent with the IEC, 
which defines an irradiation-event as the loading of x-ray equipment caused 
by a single continuous actuation of the equipments irradiation switch, from the 
start of the loading time of the first pulse until the loading time trailing edge of 
the final pulse.7
FDAs interpretation of 21 CFR 1020.30(b) allows for the comparison of 
fluoroscopic irradiation time among different procedures and different 
operators.  Fluoroscopic irradiation time is an indicator of operator training and 
performance separate from other radiation dose metrics, such as cumulative air 
kerma and air kerma-area product.8
  Last-Image-Hold 
21 CFR 1020.32(j) requires that fluoroscopic equipment manufactured on or 
after June 10, 2006, be equipped with means to display a last-image-hold 
image following termination of the fluoroscopic exposure.  A last-image-hold 
image is intended for review for study, consultation, or education instead of 
continuing fluoroscopy or obtaining a separate radiograph.  If the last-image-
hold image is of adequate quality, no additional radiation exposure is 
necessary, and patient radiation dose is reduced.9
21 CFR 1020.32(c) requires continuous pressure by the operator for the entire 
time of any fluoroscopic exposure.  If the fluoroscopic exposure is too short, 
the last-image-hold will not be of adequate quality.  
At present, fluoroscopy equipment should be designed so that the fluoroscopy 
exposure terminates after the release of continuous pressure by the 
                                                          
6 Miller DL, Balter S, Dixon RG, et al. Quality improvement guidelines for recording patient radiation dose 
in the medical record for fluoroscopically guided procedures. J Vasc Interv Radiol. 2012;23(1):11-8. 
7 As defined in IEC,61910-1:2014, Radiation dose documentation  Part 1: Radiation dose structured 
reports for radiography and radioscopy. 
8 Stuart S, Mayo JR, Ling A, et al. Retrospective study of the impact of fellowship training on two quality 
and safety measures in uterine artery embolization. J Am Coll Radiol. 2014;11(5):471-6; Kuon E, 
Weitmann K, Hoffmann W, et al. Efficacy of a minicourse in radiation-reducing techniques in invasive 
cardiology: a multicenter field study. JACC Cardiovascular interventions. 2014;7(4):382-90; Xu BJ, 
Duszak R, Jr., McGinnis RS, Stanfill JG, O'Rear J, An AQ. Increased fluoroscopy time for central venous 
catheter placement by radiology residents versus staff radiologists. J Am Coll Radiol. 2013;10(7):518-22; 
Frederick-Dyer KC, Faulkner AR, Chang TT, Heidel RE, Pasciak AS. Online training on the safe use of 
fluoroscopy can result in a significant decrease in patient dose. Acad Radiol. 2013;20(10):1272-7; Fazel R, 
Curtis J, Wang Y, et al. Determinants of fluoroscopy time for invasive coronary angiography and 
percutaneous coronary intervention: insights from the NCDR. Catheter Cardiovasc Interv. 
2013;82(7):1091-105. 
9 IEC, 60601-2-54:2018, Particular requirements for the basic safety and essential performance of X-ray 
equipment for radiography and radioscopy, Annex AA. 
4 Contains Nonbinding Recommendations 
fluoroscopist, regardless of the quality of the last-image-hold image.  This 
design is necessary for compliance with the FDAs performance standard (21 
CFR 1020.32(c)).10  21 CFR 1020.32(c) does not specify a maximum 
allowable time between release of continuous pressure by the fluoroscopist and 
termination of the irradiation, nor does it address obtaining a last-image-hold 
image of adequate quality following very short fluoroscopic exposures. 
FDA interprets the following scenarios as complying with the performance 
standard in 21 CFR 1020.32(c): 
  For a fluoroscopy exposure of more than 0.5 sec, the device terminates 
the exposure within 0.1 sec from the time the fluoroscopist releases 
continuous pressure.  
  For a fluoroscopy exposure of 0.5 sec or less, the device terminates the 
exposure within 0.5 sec from the time the fluoroscopist releases 
continuous pressure.  
These termination times address the fact that fluoroscopic irradiation cannot 
cease instantaneously with release of continuous pressure by the fluoroscopist, 
due to unavoidable delays imposed by the operation of the necessary electronic 
circuitry, and provide enough time to create a last-image-hold image that is of 
adequate quality, as this improves patient safety. 
This interpretation should not be unduly burdensome, as it is identical to the 
measure described in IEC standard 60601-2-54.11 This approach, which 
clarifies the maximum time between release of continuous pressure by the 
fluoroscopist and termination of the irradiation exposure, will help reduce 
unnecessary radiation exposure of patients and will also allow usable last-
image-hold images to be obtained. 
  Emergency Fluoroscopy Mode 
In the case of an equipment malfunction, it is desirable that a fluoroscope 
intended for use in interventional procedures enter an emergency fluoroscopy 
mode, during which time fluoroscopy continues in a limited mode while the 
fluoroscope attempts to return to normal function.  This is an important safety 
feature for these types of procedures. 
FDAs performance standard requires, in 21 CFR 1020.32(f), (h), (j), and (k), 
that x-ray tube potential and current, fluoroscopic irradiation time, and values 
of air kerma rate and cumulative air kerma be displayed continuously, and that 
a last-image-hold be displayed following termination of the fluoroscopic 
                                                          
10 It is also consistent with IEC, 60601-1-3:2008/AMD1:2013, General requirements for basic safety and 
essential performance  Collateral standard: Radiation protection in diagnostic X-ray equipment, 
subclause 6.2.1. 
11 IEC standard 60601-2-54, subclause 203.6.2.1 (Normal initiation and termination of the irradiation). 
5 Contains Nonbinding Recommendations 
exposure, among other things.  These displays, however, may not be available 
in emergency fluoroscopy mode. 
Emergency fluoroscopy mode typically involves fluoroscopy in the mode of 
operation which was used at the time of the recoverable equipment failure, or, 
if this is not possible, fluoroscopy in the mode of operation as close as possible 
to the one which was used at the time of the recoverable equipment failure; 
normal operation of the tabletop; normal operation of the gantry; normal 
operation of tableside controls for all functions described above; normal 
operation of irradiation and motion disabling switches; and normal operation of 
anti-collision functions. 
If, at the time of the malfunction, the operator is performing a task for which 
fluoroscopy is critical (e.g., angioplasty, intravascular stent placement, 
embolization), the rapid restoration of limited fluoroscopy capability may 
prevent a catastrophic complication to the patient.  The limited functionality 
provided by the emergency fluoroscopy mode will improve safety, provided 
that measures are in place for an expeditious return to a normal mode of 
operation. 
As such, we do not intend to enforce the display and other requirements of 21 
CFR 1020.32(f), (h), (j), and (k), for devices operating in the emergency 
fluoroscopy mode, where automatic or manual recovery methods from  
emergency fluoroscopy mode provide for a return to the normal mode of 
operation with all functions available (including the display requirements of 21 
CFR 1020.32) for failures from which recovery is possible as quickly as 
reasonably practicable, which generally should not exceed 10 minutes. 
This policy is based on considerations found in IEC 60601-2-43 for emergency 
fluoroscopy mode.12
                                                          
12 (Ed. 2.1., 2017) subclause 201.4.101. 
6