AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS— 510(k) K081963

Name: FDA 510(k) clearance K081963
Creator: U.S. Food and Drug Administration
Published: 2008-07-25

Substantially Equivalent

Agfa Healthcare Corporation

FDA 510(k) clearance K081963 for AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS, Substantially Equivalent on 2008-07-25. Applicant: Agfa Healthcare Corporation. Device class: 2.

Clearance details

Applicant: Agfa Healthcare Corporation
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2008-07-10
Decision date: 2008-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenville, SC, US

Download summary PDF View on FDA.gov ↗

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