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 characterization of suspicious findings.
| Device | QVCAD SYSTEM |
| Classification Name | Analyzer, Medical Image |
| Generic Name | Analyzer, Medical Image |
| Applicant | QView Medical, Inc. |
| Date Received | 2015-11-23 |
| Decision Date | 2016-11-09 |
| Notice Date | 2016-11-16 |
| PMA | P150043 |
| Supplement | S |
| Product Code | MYN |
| Docket Number | 16M-3914 |
| Advisory Committee | Radiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | QView Medical, Inc. 4546 El Camino Real suite 215 los Altos, CA 94022 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P150043 | | Original Filing |
| S001 |
2017-06-14 |
Normal 180 Day Track |
NIH GUDID Devices