Company ยท BE
Agfa Healthcare N.V.
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2025. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 13 |
| LLZ | System, Image Processing, Radiological | 8 |
| KPR | System, X-Ray, Stationary | 2 |
| IZL | System, X-Ray, Mobile | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 1 |
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 15, 2025 | K252199 | AGFA HealthCare Enterprise Imaging Agfa Healthcare N.V., BE | LLZ |
| Apr 5, 2018 | K180589 | DR 800 with MUSICA Dynamic Agfa Healthcare N.V., BE | JAA |
| Oct 13, 2017 | K172784 | DX-D Imaging Package Agfa Healthcare N.V., BE | MQB |
| Jul 3, 2017 | K170434 | Enterprise Imaging XERO Viewer 8.1 Agfa Healthcare N.V., BE | LLZ |
| Sep 22, 2016 | K161368 | DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) Agfa Healthcare N.V., BE | MQB |
| Jun 22, 2016 | K161061 | IMPAX Volume Viewing 4.0 Agfa Healthcare N.V., BE | LLZ |
| Dec 11, 2015 | K152639 | DR 600 Agfa Healthcare N.V., BE | MQB |
| Jun 1, 2015 | K143397 | ICIS View Agfa Healthcare N.V., BE | LLZ |
| Jan 6, 2015 | K142316 | IMPAX Agility Agfa Healthcare N.V., BE | LLZ |
| Oct 16, 2014 | K142184 | DX-D IMAGING PACKAGE Agfa Healthcare N.V. | MQB |
| Sep 12, 2014 | K141602 | DX-D IMAGING PACKAGE Agfa Healthcare N.V. | MQB |
| Jun 6, 2014 | K141192 | DR 400 Agfa Healthcare N.V. | MQB |
| Mar 7, 2014 | K133135 | IMPAX VOLUME VIEWING 3.0 Agfa Healthcare N.V., BE | LLZ |
| Mar 3, 2014 | K132800 | SKINTELL Agfa Healthcare N.V. | NQQ |
| Aug 29, 2013 | K131408 | CR 12-X DIGITIZER Agfa Healthcare N.V. | MQB |
| Mar 11, 2013 | K122736 | DX-D IMAGING PACKAGE Agfa Healthcare N.V. | MQB |
| Aug 16, 2012 | K121095 | DX-D IMAGING PACKAGE Agfa Healthcare N.V. | MQB |
| Jul 20, 2012 | K121948 | CR 10-X DIGITIZER Agfa Healthcare N.V., BE | MQB |
| Dec 22, 2011 | K111324 | CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER Agfa Healthcare N.V. | MUE |
| Oct 27, 2011 | K112670 | DX-D 600 Agfa Healthcare N.V. | KPR |
| Aug 5, 2011 | K111945 | IMPAX NEXT GENERATION Agfa Healthcare N.V., BE | LLZ |
| Jun 24, 2011 | K111638 | IMPAX VOLUME VIEWING Agfa Healthcare N.V., BE | LLZ |
| Jan 3, 2011 | K103597 | DX-D 100 Agfa Healthcare N.V. | IZL |
| Oct 29, 2010 | K103050 | DX-D 300 Agfa Healthcare N.V. | KPR |
| Nov 6, 2009 | K092669 | DX-D IMAGING PACKAGE Agfa Healthcare N.V., BE | MQB |
| Aug 11, 2009 | K092238 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS Agfa Healthcare N.V., BE | MQB |
| May 18, 2009 | K090672 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS Agfa Healthcare N.V., BE | MQB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||