Agfa Healthcare N.V.

US Last updated 23 May 2026

Devices: 26
Registries: FDA 510(k)FDA
FDA recalls: 0

Catalogue26

DX-D Imaging Package Ref K172784

Class II FDA 510(k) Active
DR 800 with MUSICA Dynamic Ref K180589

Class II FDA 510(k) Active
Dx-D Imaging Package Ref K092669

Class II FDA 510(k) Active
ICIS View Ref K143397

Class II FDA 510(k) Active
Dx-D Imaging Package Ref K121095

Class II FDA 510(k) Active
IMPAX Agility Ref K142316

Class II FDA 510(k) Active
Agfa Computed Radiography Systems With Dx-G Digitizers Ref K092238

Class II FDA 510(k) Active
IMPAX Volume Viewing 4.0 Ref K161061

Class II FDA 510(k) Active
Dx-D 300 Ref K103050

Class II FDA 510(k) Active
Dx-D 600 Ref K112670

Class II FDA 510(k) Active
Dx-D Imaging Package Ref K122736

Class II FDA 510(k) Active
Impax Next Generation Ref K111945

Class II FDA 510(k) Active
Enterprise Imaging XERO Viewer 8.1 Ref K170434

Class II FDA 510(k) Active
Dx-D Imaging Package Ref K141602

Class II FDA 510(k) Active
Dx-D 100 Ref K103597

Class II FDA 510(k) Active
Cr 12-X Digitizer Ref K131408

Class II FDA 510(k) Active
Cr Mammography System With Dx-M Digitizer Ref K111324

Class II FDA 510(k) Active
Dr 600 Ref K152639

Class II FDA 510(k) Active
Skintell Ref K132800

Class II FDA 510(k) Active
Dx-D Imaging Package Ref K142184

Class II FDA 510(k) Active
DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) Ref K161368

Class II FDA 510(k) Active
Impax Volume Viewing 3.0 Ref K133135

Class II FDA 510(k) Active
Agfa Computed Radiography Systems With Nx Workstations Ref K090672

Class II FDA 510(k) Active
Impax Volume Viewing Ref K111638

Class II FDA 510(k) Active
Cr 10-X Digitizer Ref K121948

Class II FDA 510(k) Active
Dr 400 Ref K141192

Class II FDA 510(k) Active

FDA establishments1

Registered with the FDA under this company group, matched by name.

Agfa Healthcare N.V. MORTSEL Antwerpen · BE FEI 3009471886

Information

Country: US

Catalogue26

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

Agfa Computed Radiography Systems With Dx-G Digitizers Ref K092238

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

DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) Ref K161368

Impax Volume Viewing 3.0 Ref K133135

Agfa Computed Radiography Systems With Nx Workstations Ref K090672

Impax Volume Viewing Ref K111638

Cr 10-X Digitizer Ref K121948

Dr 400 Ref K141192

FDA establishments1

Information