| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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054
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Date of Entry 07/06/2020
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FR Recognition Number
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9-128
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| CIE ISO 11664-6 First edition 2014-02-01 Colorimetry - Part 6: CIEDE2000 colour-difference formula |
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Scope/Abstract| This CIE International Standard specifies the method of calculating colour differences according to the CIEDE2000 formula.
The Standard is applicable to input values of CIELAB L*, a*, b* coordinates calculated according to ISO 11664-4:2008(E)/CIE S 014-4/E:2007. The Standard may 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. The Standard 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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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §876.1500 |
Angioscope |
Class 2 |
LYK |
| §876.1500 |
Anoscope And Accessories |
Class 2 |
FER |
| §876.1500 |
Choledochoscope And Accessories, Flexible/Rigid |
Class 2 |
FBN |
| §876.1500 |
Colonoscope And Accessories, Flexible/Rigid |
Class 2 |
FDF |
| §876.1500 |
Cystoscope And Accessories, Flexible/Rigid |
Class 2 |
FAJ |
| §876.1500 |
Cystourethroscope |
Class 2 |
FBO |
| §876.1500 |
Duodenoscope And Accessories, Flexible/Rigid |
Class 2 |
FDT |
| §876.1500 |
Endoscope, Flexible |
Class 2 |
GCQ |
| §876.1500 |
Endoscope, Rigid |
Class 2 |
GCM |
| §876.1500 |
Enteroscope And Accessories |
Class 2 |
FDA |
| §876.1500 |
Kit, Nephroscope |
Class 2 |
FGA |
| §876.1500 |
Laparoscope, General & Plastic Surgery |
Class 2 |
GCJ |
| §876.1500 |
Resectoscope |
Class 2 |
FJL |
| §876.1500 |
Sigmoidoscope And Accessories, Flexible/Rigid |
Class 2 |
FAM |
| §876.1500 |
Sigmoidoscope, Rigid, Electrical |
Class 2 |
FAN |
| §876.1500 |
Telescope, Rigid, Endoscopic |
Class 2 |
FBP |
| §876.1500 |
Ureteroscope And Accessories, Flexible/Rigid |
Class 2 |
FGB |
| §876.1500 |
Urethroscope |
Class 2 |
FGC |
| §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 |
Falloposcope |
Class 2 |
MKO |
| §884.1690 |
Hysteroscope (And Accessories) |
Class 2 |
HIH |
| §884.1720 |
Laparoscope, Gynecologic (And Accessories) |
Class 2 |
HET |
| §864.1860 |
Automated Digital Image Manual Interpretation Microscope |
Class 2 |
OEO |
| §864.3700 |
Digital Pathology Display |
Class 2 |
PZZ |
| §864.3700 |
Digital Pathology Image Viewing And Management Software |
Class 2 |
QKQ |
| §864.3700 |
Whole Slide Imaging System |
Class 2 |
PSY |
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Relevant FDA Guidance and/or Supportive Publications*
* Submission Guidance for a 510(k): Hysteroscopes and Gynecologic Laparoscopes, Issued March 7, 1996.
* Guidance for Industry and FDA Staff: Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices, Issued April 2016.
* Cheng, W.C., Saleheen, F., and Badano, A. (2019). Assessing color performance of whole-slide imaging scanners for digital pathology. Color Research & Application, 44(3), 322-334.
* Lemaillet P. & Cheng W.C. (2020). Colorimetrical uncertainty of a hyperspectral imaging microscopy system for assessing whole-slide imaging devices. Biomedical Optics Express, 11(3), 1449-1461. |
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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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