Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Agfa Healthcare Corp. · 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) |
|---|---|---|---|---|---|
| K071972 | ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS | Agfa Healthcare Corp. | 2007-07-30 | 13 | 0 |
| K071297 | IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION) | Agfa Healthcare Corp. | 2007-06-22 | 44 | 1 |
| K071162 | AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS | Agfa Healthcare Corp. | 2007-05-08 | 12 | 2 |
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