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FDA 510(k)

FDX Console (DR-ID300CL) Software

K-Number: K170451 · 2017-03-16

ApplicantFujifilm Medical Systems U.S.A, Inc.
Decision Date2017-03-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FDX Console (DR-ID300CL) Software is a medical device manufactured by Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2017-03-16 under approval number K170451. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FDX Console (DR-ID300CL) Software?

FDX Console (DR-ID300CL) Software is a medical device that received FDA 510(k) clearance on 2017-03-16. It is manufactured by Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K170451.

When was FDX Console (DR-ID300CL) Software approved by the FDA?

FDX Console (DR-ID300CL) Software received FDA 510(k) clearance on 2017-03-16, under approval number K170451.

What company makes FDX Console (DR-ID300CL) Software?

FDX Console (DR-ID300CL) Software is manufactured by Fujifilm Medical Systems U.S.A, Inc..

What is the FDA product code for FDX Console (DR-ID300CL) Software?

The FDA product code for FDX Console (DR-ID300CL) Software is LLZ.

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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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