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.
| Device | QVCAD System (Version 3.3) |
| Classification Name | Analyzer, Medical Image |
| Generic Name | Analyzer, Medical Image |
| Applicant | QView Medical, Inc. |
| Date Received | 2017-06-14 |
| Decision Date | 2017-12-14 |
| PMA | P150043 |
| Supplement | S001 |
| Product Code | MYN |
| Advisory Committee | Radiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | QView Medical, Inc. 4546 El Camino Real suite 215 los Altos, CA 94022 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P150043 | | Original Filing |
| S001 |
2017-06-14 |
Normal 180 Day Track |
NIH GUDID Devices