DX-D IMAGING PACKAGE— 510(k) K122736

Substantially Equivalent

Agfa Healthcare N.V.

FDA 510(k) clearance K122736 for DX-D IMAGING PACKAGE, Substantially Equivalent on 2013-03-11. Applicant: Agfa Healthcare N.V.. Device class: 2.

Clearance details

Applicant
Agfa Healthcare 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
Brevard, NC, US
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