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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
ApplicantVUCOMP, INC.
PMA NumberP100005
Date Received02/01/2010
Decision Date01/23/2012
Product Code
MYN[ Registered Establishments with MYN ]
Docket Number 12M-0082
Notice Date 01/26/2012
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 m-vu algorithm engine. The device is indicated for use in screening mammography to identify areas consistent with breast cancer for radiologist review after completing an initial read.
Approval Order Approval Order
Supplements: S001 S002 S003 S004