QVCAD System is an AI-enabled medical device from QView Medical, Inc., listed by FDA (PMA, P150043) with a decision date of 2016-11-09. Review panel: Radiology.
| FDA submission number | P150043 |
|---|---|
| Pathway | PMA |
| Company | QView Medical, Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2016-11-09 |
| Product code | MYN |
| Classification | Analyzer, Medical Image |
| Device class | 2 |
| Regulation number | 892.2070 |
| Review time (calendar days) | 352 |
Official FDA database record · FDA AI-enabled device list
All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.