Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Viz. Ai, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
123 daysmedian FDA review time
182 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250354 | Viz Subdural+, Viz SUBDURAL PLUS | Viz. Ai, Inc. | 2025-06-10 | 123 | 0 |
| K232363 | Viz HDS, Viz Volume Plus, Viz ICH+ | Viz. Ai, Inc. | 2024-02-05 | 182 | 0 |
| DEN230003 | Viz HCM | Viz. Ai, Inc. | 2023-08-03 | 205 | 0 |
| K223443 | Viz AAA | Viz. Ai, Inc. | 2023-03-17 | 123 | 0 |
| K223042 | Viz LVO ContaCT | Viz. Ai, Inc. | 2022-10-21 | 22 | 0 |
| K221100 | Viz RV/LV | Viz. Ai, Inc. | 2022-08-29 | 137 | 0 |
| K220439 | Viz SDH | Viz. Ai, Inc. | 2022-07-25 | 159 | 0 |
| K213319 | Viz ANEURYSM, Viz ANX | Viz. Ai, Inc. | 2022-02-18 | 137 | 0 |
| K210209 | Viz ICH | Viz. Ai, Inc. | 2021-03-23 | 56 | 0 |
| K193658 | Viz ICH | Viz. Ai, Inc. | 2020-03-18 | 79 | 0 |
| K180161 | Viz CTP | Viz. Ai, Inc. | 2018-04-20 | 91 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda