FDR D-EVO III flat panel detector system— 510(k) K192932

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K192932 for FDR D-EVO III flat panel detector system, Substantially Equivalent on 2019-11-12. Applicant: Fujifilm Corporation.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code MQB
Advisory panel: Radiology
Date received: 2019-10-17
Decision date: 2019-11-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Ashigara Kami-Gun, JP

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