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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameIMAGE CHECKER (CAD) SYSTEM, M100
Classification Nameanalyzer,medical image
Generic Nameimage analysis system
ApplicantR2 TECHNOLOGY, INC.
PMA NumberP970058
Supplement NumberS011
Date Received09/28/2001
Decision Date11/13/2001
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of the imagechecker m1000 with input from the general electric medical systems' senographe 2000 full field digital mammography system.
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