The following data is part of a premarket notification filed by Nines, Inc. with the FDA for Ninesai.
| Device ID | K193351 |
| 510k Number | K193351 |
| Device Name: | NinesAI |
| Classification | Radiological Computer-assisted Triage And Notification Software |
| Applicant | Nines, Inc. 329 Alma St. Palo Alto, CA 94301 |
| Contact | Russell Stewart |
| Correspondent | John J. Smith Hogan Lovells US LLP 555 13th Street, 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 | 2019-12-03 |
| Decision Date | 2020-04-21 |