11 devices · 2 companies · 2018 to 2025
Viz.ai, Inc.: AI-enabled devices on FDA's list
11 devices from Viz.ai, Inc., 2018 to 2025, from 2 companies across 5 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (11 of 11 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Viz.ai, Inc.
- QAS · Radiological Computer-Assisted Triage And Notification Software4
- QIH · Automated Radiological Image Processing Software3
- QFM · Radiological Computer-Assisted Prioritization Software For Lesions2
- QXO · Cardiovascular Machine Learning-Based Notification Software1
- LLZ · System, Image Processing, Radiological1
Panels
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Viz Subdural+, Viz SUBDURAL PLUSK250354 · 510(k) | Radiology | QIH | database entry | |
| Viz HDS, Viz Volume Plus, Viz ICH+K232363 · 510(k) | Radiology | QIH | database entry | |
| Viz HCMDEN230003 · De Novo | Cardiovascular | QXO | database entry | |
| Viz AAAK223443 · 510(k) | Radiology | QFM | database entry | |
| Viz LVO ContaCTK223042 · 510(k) | Radiology | QAS | database entry | |
| Viz RV/LVK221100 · 510(k) | Radiology | QIH | database entry | |
| Viz SDHK220439 · 510(k) | Radiology | QAS | database entry | |
| Viz ANEURYSM, Viz ANXK213319 · 510(k) | Radiology | QFM | database entry | |
| Viz ICHK210209 · 510(k) | Radiology | QAS | database entry | |
| Viz ICHK193658 · 510(k) | Radiology | QAS | database entry | |
| Viz CTPK180161 · 510(k) | Radiology | LLZ | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.