DX-D Imaging Package with XD Detectors— 510(k) K211790

Substantially Equivalent

Agfa N.V.

FDA 510(k) clearance K211790 for DX-D Imaging Package with XD Detectors, Substantially Equivalent on 2021-07-30. Applicant: Agfa N.V.. Device class: 2.

Clearance details

Applicant
Agfa N.V.
Product code
Code MQB
Device class
Class 2
Regulation
21 CFR 892.1680
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mortsel, BE
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