Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Agfa Healthcare N.V. · Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
178 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252199 | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | 2025-10-15 | 93 | 0 |
| K180589 | DR 800 with MUSICA Dynamic | Agfa Healthcare N.V. | 2018-04-05 | 30 | 1 |
| K172784 | DX-D Imaging Package | Agfa Healthcare N.V. | 2017-10-13 | 28 | 0 |
| K170434 | Enterprise Imaging XERO Viewer 8.1 | Agfa Healthcare N.V. | 2017-07-03 | 140 | 2 |
| K161368 | DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s) | Agfa Healthcare N.V. | 2016-09-22 | 128 | 0 |
| K161061 | IMPAX Volume Viewing 4.0 | Agfa Healthcare N.V. | 2016-06-22 | 68 | 0 |
| K152639 | DR 600 | Agfa Healthcare N.V. | 2015-12-11 | 87 | 0 |
| K143397 | ICIS View | Agfa Healthcare N.V. | 2015-06-01 | 187 | 0 |
| K142316 | IMPAX Agility | Agfa Healthcare N.V. | 2015-01-06 | 140 | 0 |
| K142184 | DX-D IMAGING PACKAGE | Agfa Healthcare N.V. | 2014-10-16 | 69 | 0 |
| K141602 | DX-D IMAGING PACKAGE | Agfa Healthcare N.V. | 2014-09-12 | 88 | 0 |
| K141192 | DR 400 | Agfa Healthcare N.V. | 2014-06-06 | 29 | 0 |
| K133135 | IMPAX VOLUME VIEWING 3.0 | Agfa Healthcare N.V. | 2014-03-07 | 154 | 0 |
| K132800 | SKINTELL | Agfa Healthcare N.V. | 2014-03-03 | 178 | 0 |
| K131408 | CR 12-X DIGITIZER | Agfa Healthcare N.V. | 2013-08-29 | 106 | 0 |
| K122736 | DX-D IMAGING PACKAGE | Agfa Healthcare N.V. | 2013-03-11 | 173 | 0 |
| K121095 | DX-D IMAGING PACKAGE | Agfa Healthcare N.V. | 2012-08-16 | 127 | 0 |
| K121948 | CR 10-X DIGITIZER | Agfa Healthcare N.V. | 2012-07-20 | 17 | 1 |
| K111324 | CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER | Agfa Healthcare N.V. | 2011-12-22 | 225 | 0 |
| K112670 | DX-D 600 | Agfa Healthcare N.V. | 2011-10-27 | 43 | 3 |
| K111945 | IMPAX NEXT GENERATION | Agfa Healthcare N.V. | 2011-08-05 | 28 | 1 |
| K111638 | IMPAX VOLUME VIEWING | Agfa Healthcare N.V. | 2011-06-24 | 11 | 0 |
| K103597 | DX-D 100 | Agfa Healthcare N.V. | 2011-01-03 | 26 | 6 |
| K103050 | DX-D 300 | Agfa Healthcare N.V. | 2010-10-29 | 14 | 0 |
| K092669 | DX-D IMAGING PACKAGE | Agfa Healthcare N.V. | 2009-11-06 | 67 | 1 |
| K092238 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS | Agfa Healthcare N.V. | 2009-08-11 | 19 | 2 |
| K090672 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS | Agfa Healthcare N.V. | 2009-05-18 | 66 | 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