Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cedara Software Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
67 daysmedian FDA review time
274 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092915 | CEDARA WEBACCESS, MODEL: 2.4 | Cedara Software Corp. | 2010-06-23 | 274 | 0 |
| K053301 | CEDARA I-RESPONSE CEDARA PET/CT | Cedara Software Corp. | 2006-02-03 | 67 | 0 |
| K040468 | CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO | Cedara Software Corp. | 2004-04-23 | 59 | 1 |
| K022881 | CEDARA I-SOFTVIEW | Cedara Software Corp. | 2002-10-22 | 53 | 2 |
| K002590 | CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOL | Cedara Software Corp. | 2000-10-31 | 71 | 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