FDR SE Lite— 510(k) K192440

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K192440 for FDR SE Lite, Substantially Equivalent on 2019-11-01. Applicant: Fujifilm Corporation.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code MQB
Advisory panel: Radiology
Date received: 2019-09-06
Decision date: 2019-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ashigarakami-Gun Kanagawa, JP

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