The following data is part of a De Novo classification by Viz.al, Inc. with the FDA for Contact.
| DeNovo ID | DEN170073 |
| Device Name: | ContaCT |
| Classification | Radiological Computer-assisted Triage And Notification Software |
| Applicant | Viz.Al, Inc. 343 Texas St. San Francisco, CA 94301 |
| Contact | Gregory Ramina |
| Product Code | QAS |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Radiology |
| Classification Advisory | Radiology |
| Type | Direct |
| Date Received | 2017-09-29 |
| Decision Date | 2018-02-13 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811852030004 | DEN170073 | 000 |
| 00811852030189 | DEN170073 | 000 |
| 00811852030172 | DEN170073 | 000 |
| 00811852030097 | DEN170073 | 000 |
| 00811852030110 | DEN170073 | 000 |
| 00811852030080 | DEN170073 | 000 |
| 00811852030073 | DEN170073 | 000 |
| 00811852030059 | DEN170073 | 000 |
| 00811852030042 | DEN170073 | 000 |
| 00811852030035 | DEN170073 | 000 |
| 00811852030301 | DEN170073 | 000 |