Viz ICH
Radiological Computer-assisted Triage And Notification Software
Viz.ai, Inc.
The following data is part of a premarket notification filed by Viz.ai, Inc. with the FDA for Viz Ich.
Pre-market Notification Details
| Device ID | K193658 |
| 510k Number | K193658 |
| Device Name: | Viz ICH |
| Classification | Radiological Computer-assisted Triage And Notification Software |
| Applicant | Viz.ai, Inc. 555 De Haro St Suite 400 San Francisco, CA 94107 |
| Contact | Gregory Ramina |
| Correspondent | Gregory Ramina Viz.ai, Inc. 555 De Haro St Suite 400 San Francisco, CA 94107 |
| Product Code | QAS |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-30 |
| Decision Date | 2020-03-18 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811852030165 | K193658 | 000 |
Trademark Results [Viz ICH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VIZ ICH 88727143 not registered Live/Pending |
Viz.ai, Inc. 2019-12-13 |
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