Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-166: NEMA XR 23-2006, "Quality Control Manual" Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography. (Radiology)
Date of Standard: 2006. |
| Address of Standards Organization: |
| National Electrical Manufacturers Association (NEMA) |
| 1300 North 17th Street |
| Suite 1847 |
| Rosslyn, VA 22209 |
| |
|
| CDRH Office and Division Associated with Recognized Standards: |
| ALL OFFICES AND DIVISIONS IN CDRH |
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| Devices Affected: |
| Full Field Digital Mammography Display |
|
| Processes Affected: |
|
| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.1715 |
Full Field Digital,System,X-Ray,Mammographic |
Class 2 |
MUE |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.2050 |
System, Image Processing, Radiological |
Class 2 |
LLZ |
| |
|
| Relevant Guidance: |
Guidance for Industry
Guidance for the Submission of Premarktet Notifications for Medical Image Management Devices. Document issued on: July 27, 2000
Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDA. Document issued on February 16, 2001 |
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| FDA Technical Contact: |
| Kish Chakrabarti |
| FDA/CDRH/OIVD |
| 10903 New Hampshire Avenue Building 66, Room G308 |
| Silver Spring MD 20993 |
| 301/796-6539 |
| Email: kish.chakrabarti@fda.hhs.gov |
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