QVCAD System (Version 3.3)
FDA premarket approval P150043/S001 · decided 2017-12-14
Approval details
- PMA number
- P150043
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- QVCAD System (Version 3.3)
- Generic name
- Analyzer, medical image
- Applicant
- Qview Medical, Inc.
- Date received
- 2017-06-14
- Decision date
- 2017-12-14
- Days to decision
- 183 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Los Altos, CA
- 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 somov 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 fo
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