The following data is part of a premarket notification filed by Viz.ai, Inc. with the FDA for Viz Ctp.
| Device ID | K180161 |
| 510k Number | K180161 |
| Device Name: | Viz CTP |
| Classification | System, Image Processing, Radiological |
| Applicant | Viz.ai, Inc. 855 El Camino Real Suit 13A-252 Palo Alto, CA 94301 |
| Contact | Gregory Ramina |
| Correspondent | Gregory Ramina Viz.ai, Inc. 855 El Camino Real Suit 13A-252 Palo Alto, CA 94301 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-19 |
| Decision Date | 2018-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811852030011 | K180161 | 000 |
| 00811852030066 | K180161 | 000 |
| 00811852030103 | K180161 | 000 |
| 00811852030288 | K180161 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VIZ CTP 88727112 not registered Live/Pending |
Viz.ai, Inc. 2019-12-13 |