PMA P150043S001

Device: QVCAD System (Version 3.3)
Applicant: Qview Medical, Inc.
PMA number: P150043
Supplement: S001
Product code: MYN
Decision date: 2017-12-14
Classification: Analyzer, Medical Image
Generic name: Analyzer, medical image
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.

Current openFDA PMA Record#

Device: QVCAD System (Version 3.3)
Applicant: Qview Medical, Inc.
PMA number: P150043
Supplement: S001
Product code: MYN
Generic name: Analyzer, medical image
Decision date: 2017-12-14
Decision code: APPR
Date received: 2017-06-14
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.