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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.
 
DeviceQVCAD SYSTEM
Classification Nameanalyzer, medical image
Generic Nameanalyzer, medical image
Applicant
QView Medical, Inc.
4546 el camino real
suite 215
los altos, CA 94022
PMA NumberP150043
Date Received11/23/2015
Decision Date11/09/2016
Product Code
MYN[ Registered Establishments with MYN ]
Docket Number 16M-3914
Notice Date 11/16/2016
Advisory Committee Radiology
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 
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