Viz. Ai, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Viz. Ai, Inc.” (first 2018, latest 2025), plus 1 De Novo decision, across 5 product codes in 2 review panels. Median 510(k) review time under this name: 123 days. Since 2017 the median was 123 days, against 129 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 91 |
| 2019 | 0 | — |
| 2020 | 1 | 79 |
| 2021 | 1 | 56 |
| 2022 | 4 | 137 |
| 2023 | 1 | 123 |
| 2024 | 1 | 182 |
| 2025 | 1 | 123 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Viz. Ai, Inc. took a median 123 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 129 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QAS | Radiological Computer-Assisted Triage And Notification Software | 4 | 4 |
| QIH | Automated Radiological Image Processing Software | 3 | 3 |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | 2 | 2 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| QXO | Cardiovascular Machine Learning-Based Notification Software | 1 | 0 |
Review panels
- Radiology (10)
- Cardiovascular (1)
Most recent Viz. Ai, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250354 | Viz Subdural+, Viz SUBDURAL PLUS | QIH | 2025-06-10 | 123 |
| K232363 | Viz HDS, Viz Volume Plus, Viz ICH+ | QIH | 2024-02-05 | 182 |
| K223443 | Viz AAA | QFM | 2023-03-17 | 123 |
| K223042 | Viz LVO ContaCT | QAS | 2022-10-21 | 22 |
| K221100 | Viz RV/LV | QIH | 2022-08-29 | 137 |
| K220439 | Viz SDH | QAS | 2022-07-25 | 159 |
| K213319 | Viz ANEURYSM, Viz ANX | QFM | 2022-02-18 | 137 |
| K210209 | Viz ICH | QAS | 2021-03-23 | 56 |
| K193658 | Viz ICH | QAS | 2020-03-18 | 79 |
| K180161 | Viz CTP | LLZ | 2018-04-20 | 91 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230003 | De Novo | Cardiovascular Machine Learning-Based Notification Software | 2023-08-03 |
Recalls
openFDA lists no recalls under a recalling firm named Viz. Ai, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Viz. Ai, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07103057: VIZ ACCESS HCM - Multi-Site Registry (Recruiting, started 2025-06-13)
- NCT04608617: SYNCHRONISE: LVO Triage Timing and Outcome Study (Completed, started 2021-03-09)
- NCT04733638: ADVANCE- Automated Detection and Volumetric Assessment of ICH (Completed, started 2021-01-26)
- NCT03865979: AI ENRICH - AI Detection of ICH (Completed, started 2020-01-23)
Frequently asked questions
How many FDA 510(k) clearances are listed under Viz. Ai, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Viz. Ai, Inc.” (first 2018, latest 2025), plus 1 De Novo decision, across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Viz. Ai, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Viz. Ai, Inc. is 123 days. Since 2017: 123 days, versus 129 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Viz. Ai, Inc.?
The most frequent FDA product codes under this applicant name are 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).
Next steps
- See all 10 Viz. Ai, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QAS, Viz. Ai, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.