Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Agfa Corporation — 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) |
|---|---|---|---|---|---|
| K062742 | CR 85-X | Agfa Corporation | 2006-10-13 | 29 | 0 |
| K062223 | AGFA MODEL CR30-X | Agfa Corporation | 2006-09-01 | 30 | 0 |
| K053634 | COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION | Agfa Corporation | 2006-01-17 | 19 | 0 |
| K052251 | DRYSTAR MODEL 5500 | Agfa Corporation | 2005-08-31 | 13 | 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