Part B: Supplementary Information Sheet (SIS) |
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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9-124
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Standard | |
ISO CIE 11664-1:2019 Colorimetry - Part 1: CIE standard colorimetric observers |
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Scope/AbstractThis document specifies colour-matching functions for use in colorimetry. Two sets of colour-matching functions are specified. a) Colour-matching functions for the CIE 1931 standard colorimetric observer. This set of colour-matching functions is representative of the colour-matching properties of observers with normal colour vision for visual field s of angular subtense from about 1° to about 4°, for vision at photopic levels of adaptation. b) Colour-matching functions for the CIE 1964 standard colorimetric observer. This set of clour-matching functions is representative of the colour-matching properties of observers with normal colour vision for visual field s of angular subtense greater than about 4°, for vision at sufficiently high photopic levels and with spectral power distributions such that no participation of the rod receptors of the retina is to be expected. |
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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. |