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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 the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2017-03-16 under 510(k) 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. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K170451.

When did FDX Console (DR-ID300CL) Software receive FDA 510(k) clearance?

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

Who is the listed applicant for FDX Console (DR-ID300CL) Software?

The FDA 510(k) record lists Fujifilm Medical Systems U.S.A, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Fujifilm Medical Systems U.S.A, Inc. as applicant

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Related Devices (Code: 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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