DR 600— 510(k) K152639

Substantially Equivalent

Agfa Healthcare N.V.

FDA 510(k) clearance K152639 for DR 600, Substantially Equivalent on 2015-12-11. 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: 2015-09-15
Decision date: 2015-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mortsel, BE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.