Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Agfa N.V. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
53 daysmedian FDA review time
104 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213469 | VALORY | Agfa N.V. | 2021-11-18 | 21 | 0 |
| K212145 | DR 800 with DSA, DR 800 | Agfa N.V. | 2021-08-31 | 53 | 0 |
| K211790 | DX-D Imaging Package with XD Detectors | Agfa N.V. | 2021-07-30 | 50 | 0 |
| K193262 | DR 600 with Tomosynthesis | Agfa N.V. | 2020-03-09 | 104 | 0 |
| K191884 | DR 100s | Agfa N.V. | 2019-08-09 | 25 | 0 |
| K183275 | DR 800 with Tomosynthesis | Agfa N.V. | 2019-02-01 | 70 | 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