FDR D-EVO II FLAT PANEL DETECTOR SYSTEM— 510(k) K142003

Substantially Equivalent

Fujifilm Medical System U.S.A., Inc.

FDA 510(k) clearance K142003 for FDR D-EVO II FLAT PANEL DETECTOR SYSTEM, Substantially Equivalent on 2014-10-21. Applicant: Fujifilm Medical System U.S.A., Inc..

Clearance details

Applicant: Fujifilm Medical System U.S.A., Inc.
Product code: Code MQB
Advisory panel: Radiology
Date received: 2014-07-23
Decision date: 2014-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, US

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