The following data is part of a premarket notification filed by Avicenna.ai with the FDA for Cina Chest.
| Device ID | K210237 |
| 510k Number | K210237 |
| Device Name: | CINA CHEST |
| Classification | Radiological Computer-assisted Triage And Notification Software |
| Applicant | Avicenna.AI 93 Avenue Du Sorbiers, Zone Athelia IV La Ciotat, FR 13600 |
| Contact | Stephane Berger |
| Correspondent | John J. Smith Hogan Lovells US LLP 555 13th St. NW Washington, DC 20004 |
| Product Code | QAS |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-28 |
| Decision Date | 2021-05-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B826CINACHEST100 | K210237 | 000 |