| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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060
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Date of Entry 05/29/2023
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FR Recognition Number
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9-148
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| Standard | |
ISO CIE 11664-6 Second edition 2022-08
Colorimetry - Part 6: CIEDE2000 colour-difference formula |
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Scope/AbstractThis 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.
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| Extent of Recognition
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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. |
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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| FDA recognition of ISO, CIE 11664-6 First edition 2014-02-01 [Rec# 9-128] will be superseded by recognition of ISO, CIE 11664-6 Second edition 2022-08 [Rec# 9-148].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. |
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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
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OEO
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| §864.3700 |
Whole Slide Imaging System
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Class 2
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PSY
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| §864.3700 |
Digital Pathology Display
|
Class 2
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PZZ
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| §864.3700 |
Digital Pathology Image Viewing And Management Software
|
Class 2
|
QKQ
|
| §874.4680 |
Bronchoscope (Flexible Or Rigid)
|
Class 2
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EOQ
|
| §874.4710 |
Esophagoscope (Flexible Or Rigid)
|
Class 2
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EOX
|
| §874.4760 |
Nasopharyngoscope (Flexible Or Rigid)
|
Class 2
|
EOB
|
| §876.1300 |
System, Imaging, Gastrointestinal, Wireless, Capsule
|
Class 2
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NEZ
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| §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
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FAJ
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| §876.1500 |
Sigmoidoscope And Accessories, Flexible/Rigid
|
Class 2
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FAM
|
| §876.1500 |
Sigmoidoscope, Rigid, Electrical
|
Class 2
|
FAN
|
| §876.1500 |
Choledochoscope And Accessories, Flexible/Rigid
|
Class 2
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FBN
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| §876.1500 |
Cystourethroscope
|
Class 2
|
FBO
|
| §876.1500 |
Telescope, Rigid, Endoscopic
|
Class 2
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FBP
|
| §876.1500 |
Enteroscope And Accessories
|
Class 2
|
FDA
|
| §876.1500 |
Colonoscope And Accessories, Flexible/Rigid
|
Class 2
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FDF
|
| §876.1500 |
Duodenoscope And Accessories, Flexible/Rigid
|
Class 2
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FDT
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| §876.1500 |
Anoscope And Accessories
|
Class 2
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FER
|
| §876.1500 |
Kit, Nephroscope
|
Class 2
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FGA
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| §876.1500 |
Ureteroscope And Accessories, Flexible/Rigid
|
Class 2
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FGB
|
| §876.1500 |
Urethroscope
|
Class 2
|
FGC
|
| §876.1500 |
Resectoscope
|
Class 2
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FJL
|
| §876.1500 |
Laparoscope, General & Plastic Surgery
|
Class 2
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GCJ
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| §876.1500 |
Endoscope, Rigid
|
Class 2
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GCM
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| §876.1500 |
Endoscope, Flexible
|
Class 2
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GCQ
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| §876.1500 |
Angioscope
|
Class 2
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LYK
|
| §876.1500 |
Endoscope, Accessories, Narrow Band Spectrum
|
Class 2
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NWB
|
| §876.1500 |
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
|
Class 2
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OCS
|
| §876.1500 |
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
|
Class 2
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ODE
|
| §876.1500 |
Endoscope, Accessories, Image Post-Processing For Color Enhancement
|
Class 2
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PEA
|
| §876.1520 |
Gastrointesinal Lesion Software Detection System
|
Class 2
|
QNP
|
| §884.1600 |
Amnioscope, Transabdominal (Fetoscope) (And Accessories)
|
HDE
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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)
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Class 2
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HET
|
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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. |
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| FDA Technical Contact
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| Standards Development Organizations
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FDA Specialty Task Groups (STG)
| ObGyn/Gastroenterology/Urology (primary) |
| Radiology |
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| *These are provided as examples and others may be applicable. |
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