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FDA 510(k)

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

K-Number: K163624 · 2017-06-30

ApplicantFujifilm Medical Systems U.S.A, Inc.
Decision Date2017-06-30
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) is a medical device manufactured by Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2017-06-30 under approval number K163624. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)?

Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) is a medical device that received FDA 510(k) clearance on 2017-06-30. It is manufactured by Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K163624.

When was Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) approved by the FDA?

Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) received FDA 510(k) clearance on 2017-06-30, under approval number K163624.

What company makes Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)?

Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) is manufactured by Fujifilm Medical Systems U.S.A, Inc..

What is the FDA product code for Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)?

The FDA product code for Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) is MQB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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