ContaCT is an AI-enabled medical device from Viz.Al, Inc., listed by FDA (De Novo, DEN170073) with a decision date of 2018-02-13. Review panel: Radiology.
| FDA submission number | DEN170073 |
|---|---|
| Pathway | De Novo |
| Company | Viz.Al, Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2018-02-13 |
| Decision | Unknown |
| Product code | QAS |
| Classification | Radiological Computer-Assisted Triage And Notification Software |
| Device class | 2 |
| Regulation number | 892.2080 |
| Review time (calendar days) | 137 |
| Applicant country | US |
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.