Agfa Healthcare N.V.
Agfa Healthcare N.V. appears in FDA public data with 0 recalls, 27 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Oct 15, 2025.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 27
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K252199 | AGFA HealthCare Enterprise Imaging | Oct 15, 2025 |
| K180589 | DR 800 with MUSICA Dynamic | Apr 5, 2018 |
| K172784 | DX-D Imaging Package | Oct 13, 2017 |
| K170434 | Enterprise Imaging XERO Viewer 8.1 | Jul 3, 2017 |
| K161368 | DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) | Sep 22, 2016 |
| K161061 | IMPAX Volume Viewing 4.0 | Jun 22, 2016 |
| K152639 | DR 600 | Dec 11, 2015 |
| K143397 | ICIS View | Jun 1, 2015 |
| K142316 | IMPAX Agility | Jan 6, 2015 |
| K142184 | DX-D IMAGING PACKAGE | Oct 16, 2014 |
| K141602 | DX-D IMAGING PACKAGE | Sep 12, 2014 |
| K141192 | DR 400 | Jun 6, 2014 |
| K133135 | IMPAX VOLUME VIEWING 3.0 | Mar 7, 2014 |
| K132800 | SKINTELL | Mar 3, 2014 |
| K131408 | CR 12-X DIGITIZER | Aug 29, 2013 |
| K122736 | DX-D IMAGING PACKAGE | Mar 11, 2013 |
| K121095 | DX-D IMAGING PACKAGE | Aug 16, 2012 |
| K121948 | CR 10-X DIGITIZER | Jul 20, 2012 |
| K111324 | CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER | Dec 22, 2011 |
| K112670 | DX-D 600 | Oct 27, 2011 |