Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)— 510(k) K163624

Substantially Equivalent

Fujifilm Medical Systems U.S.A, Inc.

FDA 510(k) clearance K163624 for Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600), Substantially Equivalent on 2017-06-30. Applicant: Fujifilm Medical Systems U.S.A, Inc.. Device class: 2.

Clearance details

Applicant
Fujifilm Medical Systems U.S.A, Inc.
Product code
Code MQB
Device class
Class 2
Regulation
21 CFR 892.1680
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Stamford, CT, US
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