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 |