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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceQVCAD System (Version 3.3)
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantQview Medical, Inc.
4546 El Camino Real, Suite 215
Los Altos, CA 94022
PMA NumberP150043
Supplement NumberS001
Date Received06/14/2017
Decision Date12/14/2017
Reclassified Date02/21/2020
Product Code MYN 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for QVCAD System (Version 3.3). 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 and Invenia Automated Breast Ultrasound Systems (screening mammography BIRADS® 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.
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