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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.
 
DeviceICAD SYSTEM
Classification Nameanalyzer,medical image
Generic Nameanalyzer,medical image
Applicant
ICAD, INC.
98 spit brook road
suite 100
nashua, NH 03062
PMA NumberP010038
Supplement NumberS004
Date Received06/18/2003
Decision Date10/10/2003
Product Code
MYN[ Registered Establishments with MYN ]
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 a change in the mammography film digitizer from the formerly approved multirad 860 to the fulcrum.
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