Medical Device Manufacturer · BE , Mortsel

Agfa Healthcare N.V. - FDA 510(k) Cleared Devices

27 submissions · 27 cleared · Since 2009

Total

Cleared

Denied

Agfa Healthcare N.V. has 27 FDA 510(k) cleared radiology devices. Based in Mortsel, BE.

Latest FDA clearance: Oct 2025. Active since 2009.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) cleared devices by Agfa Healthcare N.V.

27 devices

1-12 of 27

Cleared Oct 15, 2025

AGFA HealthCare Enterprise Imaging

K252199 · LLZ

Radiology · 93d

Cleared Apr 05, 2018

DR 800 with MUSICA Dynamic

Enterprise Imaging XERO Viewer 8.1

K170434 · LLZ

Radiology · 140d

Cleared Sep 22, 2016

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

K161368 · MQB

Radiology · 128d

Cleared Jun 22, 2016

IMPAX Volume Viewing 4.0

Agfa Healthcare N.V. - FDA 510(k) Cleared Devices

FDA 510(k) cleared devices by Agfa Healthcare N.V.

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