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

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.

510(k) submissions have been managed by Agfa Healthcare Corporation as regulatory consultant.