Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Amicas, 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) |
|---|---|---|---|---|---|
| K082144 | AMICAS PACS, VERSION 6.0 | Amicas, Inc. | 2008-09-05 | 37 | 1 |
| K073526 | AMICAS VISION SERIES PACS, MODEL 5.5 | Amicas, Inc. | 2008-03-12 | 86 | 0 |
| K062477 | AMICAS VISION SERIES PACS, MODEL 4.3 | Amicas, Inc. | 2006-10-27 | 64 | 0 |
| K022970 | AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0 | Amicas, Inc. | 2002-11-22 | 77 | 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