Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Agfa Corp. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
90 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K063421 | DX-SI | Agfa Corp. | 2006-11-22 | 9 | 0 |
| K053458 | WEB1000 | Agfa Corp. | 2005-12-22 | 9 | 2 |
| K050810 | AGFA CR50.0 | Agfa Corp. | 2005-04-21 | 21 | 2 |
| K050751 | IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X | Agfa Corp. | 2005-04-21 | 29 | 3 |
| K042779 | RADIOTHERAPY SOLUTION BASED ON CR | Agfa Corp. | 2004-10-21 | 15 | 0 |
| K041701 | AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM | Agfa Corp. | 2004-07-22 | 30 | 0 |
| K040555 | IMPAX CLIENT EMBRACE | Agfa Corp. | 2004-05-26 | 85 | 3 |
| K040344 | IMPAX OT3000 ORTHOPEDIC WORKSTATION | Agfa Corp. | 2004-05-12 | 90 | 0 |
| K032635 | DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300 | Agfa Corp. | 2003-09-24 | 29 | 0 |
| K023287 | DRYSTAR 5500 | Agfa Corp. | 2002-10-22 | 20 | 0 |
| K023020 | AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO C | Agfa Corp. | 2002-09-26 | 15 | 1 |
| K022292 | IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATI | Agfa Corp. | 2002-09-12 | 59 | 9 |
| K022658 | LR DICOM CONTROLLER | Agfa Corp. | 2002-09-06 | 28 | 0 |
| K021542 | ADC DENTAL | Agfa Corp. | 2002-08-06 | 88 | 0 |
| K012941 | DRYSTAR, MODEL 4500M | Agfa Corp. | 2001-11-29 | 90 | 0 |
| K012750 | ADC PEDIATRIC | Agfa Corp. | 2001-11-14 | 90 | 0 |
| K012010 | MODIFICATION TO LR 5200 FILM RECORDER | Agfa Corp. | 2001-09-20 | 85 | 0 |
| K010571 | ADC QS/IPD WORKSTATION | Agfa Corp. | 2001-03-28 | 30 | 1 |
| K000159 | AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO | Agfa Corp. | 2000-02-16 | 28 | 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