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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Classification Namefull field digital,system,x-ray,mammographic
Generic Namefull field digital,system,x-ray,mammographic
Regulation Number892.1715
Applicant
GE Healthcare
3000 n. grandview blvd
waukesha, WI 53188
PMA NumberP990066
Supplement NumberS002
Date Received12/19/2000
Decision Date01/08/2001
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE KODAK DRYVIEW 8610 PRINTER FOR USE WITH THE SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.
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