The following data is part of a premarket notification filed by Viz.ai, Inc. with the FDA for Viz Lvo Contact.
| Device ID | K223042 |
| 510k Number | K223042 |
| Device Name: | Viz LVO ContaCT |
| Classification | Radiological Computer-assisted Triage And Notification Software |
| 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 | QAS |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-29 |
| Decision Date | 2022-10-21 |