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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 060 Date of Entry 05/29/2023 
FR Recognition Number 9-148
ISO CIE  11664-6 Second edition 2022-08
Colorimetry - Part 6: CIEDE2000 colour-difference formula
This CIE International Standard specifies the method of calculating colour differences according to the CIEDE2000 formula.
This document is applicable to input values of CIELAB L*, a*, b* coordinates calculated according to ISO/CIE 11664-4. It can be used for the specification of the colour difference between two colour stimuli perceived as belonging to reflecting or transmitting objects. This includes displays if they are being used to simulate reflecting or transmitting objects and if the tristimulus values representing the stimuli are appropriately normalized.
This document does not apply to colour stimuli perceived as belonging to areas that appear to be emitting light as primary light sources or that appear to be specularly reflecting such light.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ISO, CIE 11664-6 First edition 2014-02-01 [Rec# 9-128] will be superseded by recognition of ISO, CIE 11664-6 Second edition 2022-08 [Rec# 9-148]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 9-128] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 9-128] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§864.1860 Automated Digital Image Manual Interpretation Microscope Class 2 OEO
§864.3700 Whole Slide Imaging System Class 2 PSY
§864.3700 Digital Pathology Display Class 2 PZZ
§864.3700 Digital Pathology Image Viewing And Management Software Class 2 QKQ
§874.4680 Bronchoscope (Flexible Or Rigid) Class 2 EOQ
§874.4710 Esophagoscope (Flexible Or Rigid) Class 2 EOX
§874.4760 Nasopharyngoscope (Flexible Or Rigid) Class 2 EOB
§876.1300 System, Imaging, Gastrointestinal, Wireless, Capsule Class 2 NEZ
§876.1300 System, Imaging, Esophageal, Wireless, Capsule Class 2 NSI
§876.1310 Magnetically Maneuvered Capsule Endoscopy System Class 2 QKZ
§876.1330 Colon Capsule Imaging System Class 2 PGD
§876.1500 Cystoscope And Accessories, Flexible/Rigid Class 2 FAJ
§876.1500 Sigmoidoscope And Accessories, Flexible/Rigid Class 2 FAM
§876.1500 Sigmoidoscope, Rigid, Electrical Class 2 FAN
§876.1500 Choledochoscope And Accessories, Flexible/Rigid Class 2 FBN
§876.1500 Cystourethroscope Class 2 FBO
§876.1500 Telescope, Rigid, Endoscopic Class 2 FBP
§876.1500 Enteroscope And Accessories Class 2 FDA
§876.1500 Colonoscope And Accessories, Flexible/Rigid Class 2 FDF
§876.1500 Duodenoscope And Accessories, Flexible/Rigid Class 2 FDT
§876.1500 Anoscope And Accessories Class 2 FER
§876.1500 Kit, Nephroscope Class 2 FGA
§876.1500 Ureteroscope And Accessories, Flexible/Rigid Class 2 FGB
§876.1500 Urethroscope Class 2 FGC
§876.1500 Resectoscope Class 2 FJL
§876.1500 Laparoscope, General & Plastic Surgery Class 2 GCJ
§876.1500 Endoscope, Rigid Class 2 GCM
§876.1500 Endoscope, Flexible Class 2 GCQ
§876.1500 Angioscope Class 2 LYK
§876.1500 Endoscope, Accessories, Narrow Band Spectrum Class 2 NWB
§876.1500 Endoscopic Video Imaging System/Component, Gastroenterology-Urology Class 2 OCS
§876.1500 Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) Class 2 ODE
§876.1500 Endoscope, Accessories, Image Post-Processing For Color Enhancement Class 2 PEA
§876.1520 Gastrointesinal Lesion Software Detection System Class 2 QNP
§884.1600 Amnioscope, Transabdominal (Fetoscope) (And Accessories) HDE HFA
§884.1630 Colposcope (And Colpomicroscope) Class 2 HEX
§884.1630 Vaginoscope And Accessories Class 2 MOK
§884.1640 Culdoscope (And Accessories) Class 2 HEW
§884.1690 Hysteroscope (And Accessories) Class 2 HIH
§884.1690 Falloposcope Class 2 MKO
§884.1720 Laparoscope, Gynecologic (And Accessories) Class 2 HET
Relevant FDA Guidance and/or Supportive Publications*
1) Hysteroscopes and Gynecology Laparoscopes - Submission Guidance for a 510(k), issued March 7, 1996.
2) Guidance for Industry and FDA Staff: Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices, issued April 2016.
3) Wei‐Chung Cheng, Firdous Saleheen, and Aldo Badano. "Assessing color performance of whole‐slide imaging scanners for digital pathology." Color Research & Application 44.3 (2019): 322-334.
4) Lemaillet, Paul, and Wei-Chung Cheng. "Colorimetrical uncertainty of a hyperspectral imaging microscopy system for assessing whole-slide imaging devices." Biomedical Optics Express 11.3 (2020): 1449-1461.
5) Cheng, Wei-Chung, et al. "Evaluating whole-slide imaging viewers used in digital pathology." Electronic Imaging 32 (2020): 1-6.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Wei-Chung Cheng
Standards Development Organizations
ISO International Organization for Standardization https://www.iso.org/
CIE International Commission on Illumination http://cie.co.at/
FDA Specialty Task Groups (STG)
ObGyn/Gastroenterology/Urology (primary)
*These are provided as examples and others may be applicable.