Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Realtimeimage, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050298 | IPACS PRISM-5.0 | Realtimeimage, Inc. | 2005-02-28 | 21 | 0 |
| K042781 | IPACS CARDIO | Realtimeimage, Inc. | 2004-10-19 | 13 | 0 |
| K041366 | IPACS ORTHO | Realtimeimage, Inc. | 2004-06-08 | 15 | 0 |
| K030751 | IPACS PRISM | Realtimeimage, Inc. | 2003-05-29 | 80 | 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