Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Change Healthcare Canada Company · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241981 | Change Healthcare Stratus Imaging PACS | Change Healthcare Canada Company | 2024-11-12 | 130 | 0 |
| K210719 | Change Healthcare Anatomical AI | Change Healthcare Canada Company | 2021-07-20 | 132 | 0 |
| K181185 | Change Healthcare Enterprise Viewer | Change Healthcare Canada Company | 2018-08-29 | 118 | 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