Company ยท US
Viz. Ai, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2025. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| QAS | Radiological Computer-Assisted Triage And Notification Software | 4 |
| QIH | Automated Radiological Image Processing Software | 3 |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | 2 |
| LLZ | System, Image Processing, Radiological | 1 |
| QXO | Cardiovascular Machine Learning-Based Notification Software | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 10, 2025 | K250354 | Viz Subdural+, Viz SUBDURAL PLUS Viz. Ai, Inc. | QIH |
| Feb 5, 2024 | K232363 | Viz HDS, Viz Volume Plus, Viz ICH+ Viz. Ai, Inc. | QIH |
| Aug 3, 2023 | DEN230003 | Viz HCM Viz. Ai, Inc. | QXO |
| Mar 17, 2023 | K223443 | Viz AAA Viz. Ai, Inc. | QFM |
| Oct 21, 2022 | K223042 | Viz LVO ContaCT Viz. Ai, Inc. | QAS |
| Aug 29, 2022 | K221100 | Viz RV/LV Viz. Ai, Inc. | QIH |
| Jul 25, 2022 | K220439 | Viz SDH Viz. Ai, Inc. | QAS |
| Feb 18, 2022 | K213319 | Viz ANEURYSM, Viz ANX Viz. Ai, Inc. | QFM |
| Mar 23, 2021 | K210209 | Viz ICH Viz. Ai, Inc. | QAS |
| Mar 18, 2020 | K193658 | Viz ICH Viz. Ai, Inc. | QAS |
| Apr 20, 2018 | K180161 | Viz CTP Viz. Ai, Inc. | LLZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||