The following data is part of a premarket notification filed by Viz.ai, Inc. with the FDA for Viz Aneurysm, Viz Anx.
| Device ID | K213319 |
| 510k Number | K213319 |
| Device Name: | Viz ANEURYSM, Viz ANX |
| Classification | Radiological Computer-assisted Prioritization Software For Lesions |
| Applicant | Viz.ai, Inc. 201 Mission St, 12th Floor San Francisco, CA 94105 |
| Contact | Gregory Ramina |
| Correspondent | Gregory Ramina Viz.ai, Inc. 201 Mission St, 12th Floor San Francisco, CA 94105 |
| Product Code | QFM |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-04 |
| Decision Date | 2022-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811852030196 | K213319 | 000 |