Agfa Healthcare N.V.
FDA registration: Belgium Last updated 23 May 2026
- Devices
- 26
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
DX-D Imaging Package Ref K172784
DR 800 with MUSICA Dynamic Ref K180589
Dx-D Imaging Package Ref K092669
ICIS View Ref K143397
Dx-D Imaging Package Ref K121095
IMPAX Agility Ref K142316
IMPAX Volume Viewing 4.0 Ref K161061
Dx-D 300 Ref K103050
Dx-D 600 Ref K112670
Dx-D Imaging Package Ref K122736
Impax Next Generation Ref K111945
Enterprise Imaging XERO Viewer 8.1 Ref K170434
Dx-D Imaging Package Ref K141602
Dx-D 100 Ref K103597
Cr 12-X Digitizer Ref K131408
Cr Mammography System With Dx-M Digitizer Ref K111324
Dr 600 Ref K152639
Skintell Ref K132800
Dx-D Imaging Package Ref K142184
Impax Volume Viewing 3.0 Ref K133135
Impax Volume Viewing Ref K111638
Cr 10-X Digitizer Ref K121948
Dr 400 Ref K141192
FDA establishments
- Agfa Healthcare N.V. MORTSEL Antwerpen · BE FEI 3009471886
Frequently asked questions
How many devices does Agfa Healthcare N.V. have in the registry?
The registry currently lists 26 devices for Agfa Healthcare N.V.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Agfa Healthcare N.V.'s devices?
Among its 26 most recently registered devices, Agfa Healthcare N.V. has devices listed in FDA 510(k) (26 devices).
What risk classes do Agfa Healthcare N.V.'s devices fall under?
Among its 26 most recently registered devices, the classes recorded for Agfa Healthcare N.V.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Agfa Healthcare N.V. in the registry?
The most recently registered devices listed for Agfa Healthcare N.V. include DX-D Imaging Package, DR 800 with MUSICA Dynamic, ICIS View and IMPAX Agility.
Which FDA establishments are linked to Agfa Healthcare N.V.?
1 FDA establishment is linked to Agfa Healthcare N.V. in the registry; they are listed on the company page.
Information
- FDA registration
- Belgium