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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 058 Date of Entry 05/30/2022 
FR Recognition Number 9-139
Standard
ISO CIE 11664-5:2016
Colorimetry - Part 5: CIE 1976 L*u*v* colour space and u',v' uniform chromaticity scale diagram
Scope/Abstract
ISO/CIE 11664-5:2016 specifies the method of calculating the coordinates of the CIE 1976 L*u*v* colour space including correlates of lightness, chroma, saturation and hue. It includes two methods for calculating Euclidean distances in this space to represent the relative perceived magnitude of colour differences. It also specifies the method of calculating the coordinates of the u′,v′ uniform chromaticity scale diagram.

ISO/CIE 11664-5:2016 is applicable to tristimulus values calculated using the colour-matching functions of the CIE 1931 standard colorimetric system or the CIE 1964 standard colorimetric system. This part of ISO/CIE 11664 may be used for the specification of colour stimuli perceived as belonging to a reflecting or transmitting object, where a three-dimensional space more uniform than tristimulus space is required. This includes self-luminous displays, like cathode ray tubes, if they are being used to simulate reflecting or transmitting objects and if the stimuli are appropriately normalized. This part of ISO/CIE 11664, as a whole, does not apply to colour stimuli perceived as belonging to an area that appears to be emitting light as a primary light source or that appears to be specularly reflecting such light. Only the u′,v′ uniform chromaticity scale diagram defined in 4.1 and the correlates of hue and saturation defined in 4.3 apply to such colour stimuli.
Extent of Recognition
Complete standard
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
Relevant FDA Guidance and/or Supportive Publications*
1. Hysteroscopes and Gynecologic Laparoscopes - Submission Guidance for a 510(k), issued March 7, 1996.
2. Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices - Guidance for Industry and FDA Staff, issued April 2016.
3. 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.
4. 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.
FDA Technical Contact
 Wei-Chung Cheng
  FDA/OC/CDRH/OSEL/DIDSR/
  301-796-5169
  Wei-Chung.Cheng@fda.hhs.gov
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)
Radiology
*These are provided as examples and others may be applicable.
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