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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameanalyzer,medical image
Generic Nameanalyzer,medical image
6273 monarch park place
longmont, CO 80503
PMA NumberP120004
Date Received03/30/2012
Decision Date08/22/2013
Product Code
MYN[ Registered Establishments with MYN ]
Docket Number 13M-1017
Notice Date 09/10/2013
Advisory Committee Radiology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the parascript® accudetect® 6. 1. 0. This device is indicated for use in screening mammography to identify areas suspicious for breast cancer for radiologist review after completing an initial read.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001