QVCAD SYSTEM
FDA premarket approval P150043 · decided 2016-11-09
Approval details
- PMA number
- P150043
- Trade name
- QVCAD SYSTEM
- Generic name
- Analyzer, medical image
- Applicant
- Qview Medical, Inc.
- Date received
- 2015-11-23
- Decision date
- 2016-11-09
- Days to decision
- 352 days
- Decision code
- APRL
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Los Altos, CA
- 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 characte
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