| 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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| Standard | |
ISO CIE 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/AbstractThis 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. |
|
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
|
OEO
|
| §864.3700 |
Whole Slide Imaging System
|
Class 2
|
PSY
|
| §864.3700 |
Digital Pathology Display
|
Class 2
|
PZZ
|
| §864.3700 |
Digital Pathology Image Viewing And Management Software
|
Class 2
|
QKQ
|
| §876.1500 |
Cystoscope And Accessories, Flexible/Rigid
|
Class 2
|
FAJ
|
| §876.1500 |
Sigmoidoscope And Accessories, Flexible/Rigid
|
Class 2
|
FAM
|
| §876.1500 |
Sigmoidoscope, Rigid, Electrical
|
Class 2
|
FAN
|
| §876.1500 |
Choledochoscope And Accessories, Flexible/Rigid
|
Class 2
|
FBN
|
| §876.1500 |
Cystourethroscope
|
Class 2
|
FBO
|
| §876.1500 |
Telescope, Rigid, Endoscopic
|
Class 2
|
FBP
|
| §876.1500 |
Enteroscope And Accessories
|
Class 2
|
FDA
|
| §876.1500 |
Colonoscope And Accessories, Flexible/Rigid
|
Class 2
|
FDF
|
| §876.1500 |
Duodenoscope And Accessories, Flexible/Rigid
|
Class 2
|
FDT
|
| §876.1500 |
Anoscope And Accessories
|
Class 2
|
FER
|
| §876.1500 |
Kit, Nephroscope
|
Class 2
|
FGA
|
| §876.1500 |
Ureteroscope And Accessories, Flexible/Rigid
|
Class 2
|
FGB
|
| §876.1500 |
Urethroscope
|
Class 2
|
FGC
|
| §876.1500 |
Resectoscope
|
Class 2
|
FJL
|
| §876.1500 |
Laparoscope, General & Plastic Surgery
|
Class 2
|
GCJ
|
| §876.1500 |
Endoscope, Rigid
|
Class 2
|
GCM
|
| §876.1500 |
Endoscope, Flexible
|
Class 2
|
GCQ
|
| §876.1500 |
Angioscope
|
Class 2
|
LYK
|
| §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)
|
Class 2
|
HET
|
|
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.
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
|
| Standards Development Organizations
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FDA Specialty Task Groups (STG)
| ObGyn/Gastroenterology/Urology (primary) |
| Radiology |
|
| *These are provided as examples and others may be applicable. |
