| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
054
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Date of Entry 07/06/2020
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|
FR Recognition Number
|
9-129
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| CIE ISO 61966-2-1 First edition 1999-10 Multimedia systems and equipment - Colour measurement and management - Part 2-1: Colour management - Default RGB colour space - sRGB [Including: Amendment 1 (2003) and Corrigendum 1 (2014)] |
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Scope/Abstract| This part of IEC 61966 is applicable to the encoding and communication of RGB colours used in computer systems and similar applications by defining encoding transformations for use in defined reference conditions.
If actual conditions differ from the reference conditions, additional rendering transformations may be required. Such additional rendering transformations are beyond the scope of this standard. |
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| Extent of Recognition
|
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 |
|
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. |
