Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Agfa Healthcare Corporation · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
15 daysmedian FDA review time
31 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081976 | IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION | Agfa Healthcare Corporation | 2008-07-28 | 17 | 1 |
| K081963 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS | Agfa Healthcare Corporation | 2008-07-25 | 15 | 0 |
| K080013 | REGISTRATION AND FUSION | Agfa Healthcare Corporation | 2008-01-17 | 14 | 0 |
| K073271 | ORTHOGON | Agfa Healthcare Corporation | 2007-12-05 | 14 | 0 |
| K072680 | DRYSTAR AXYS, MODEL EYZ4E | Agfa Healthcare Corporation | 2007-10-25 | 31 | 1 |
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