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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Nameanalyzer,medical image
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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