Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Canon Medical Informatics, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
136 daysmedian FDA review time
262 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260324 | Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Plan | Canon Medical Informatics, Inc. | 2026-05-22 | 112 | 0 |
| K252217 | CT VScore+ | Canon Medical Informatics, Inc. | 2025-11-28 | 136 | 0 |
| K243240 | Vitrea CT VScore | Canon Medical Informatics, Inc. | 2025-04-10 | 182 | 0 |
| K223261 | Open Rib | Canon Medical Informatics, Inc. | 2023-07-13 | 262 | 0 |
| K222662 | Vitrea CT Cardiac Analysis | Canon Medical Informatics, Inc. | 2022-10-14 | 42 | 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