Viz.ai Israel Ltd
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014665798 | 3014665798 | Viz.ai Israel Ltd | 1 | N | 2026-01-01 | 150 Menachem Begin Tel Aviv IL 6492105 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 220353 | 1007059041 | K250354 | Viz Subdural+, Viz SUBDURAL PLUS | QIH | 2025-06-10 |
| 220353 | 1114011390 | K232363 | Viz HDS, Viz Volume Plus, Viz ICH+ | QIH | 2024-02-05 |
| 220353 | 1345748441 | K223443 | Viz AAA | QFM | 2023-03-17 |
| 220353 | 1667346166 | K223042 | Viz LVO ContaCT | QAS | 2022-10-21 |
| 220353 | 1597330663 | K221100 | Viz RV/LV | QIH | 2022-08-29 |
| 220353 | 1971702741 | K220439 | Viz SDH | QAS | 2022-07-25 |
| 220353 | 1380350308 | K213319 | Viz ANEURYSM, Viz ANX | QFM | 2022-02-18 |
| 220353 | 1552420594 | K210209 | Viz ICH | QAS | 2021-03-23 |
| 220353 | 1792201876 | K180161 | Viz CTP | LLZ | 2018-04-20 |
| 220353 | 1773978776 | DEN230003 | Viz HCM | QXO | 2023-08-03 |
| 220353 | 1770619688 | DEN170073 | ContaCT | QAS | 2018-02-13 |