FDR GO FLEX— 510(k) K120629

Substantially Equivalent

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

FDA 510(k) clearance K120629 for FDR GO FLEX, Substantially Equivalent on 2012-08-28. 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: 2012-03-01
Decision date: 2012-08-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Stamford, CT, US

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