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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantQView Medical, Inc.
PMA NumberP150043
Date Received11/23/2015
Decision Date11/09/2016
Reclassified Date 02/21/2020
Product Code MYN 
Docket Number 16M-3914
Notice Date 11/16/2016
Advisory Committee Radiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the QVCAD System. The QVCAD System is indicated for use as an aid to the reader during screening procedures in searching images of female breasts produced by the somo.v Automated Breast Ultrasound System (screening mammography BI- RADS® Assessment Category 1 or 2, and BI-RADS Composition/Density c or d) to detect mammography-occult lesions in regions not known to have suspicious findings. The indicators produced by the QVCAD System are not intended to be used for diagnostic characterization of suspicious findings.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Supplements:  S001