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FDA 510(k)

FUJI SYNAPSE WORKSTATION SOFTWARE

K-Number: K051553 · 2005-07-07

ApplicantFujifilm Medical Systems U.S.A, Inc.
Decision Date2005-07-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FUJI SYNAPSE WORKSTATION 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 2005-07-07 under 510(k) number K051553. 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 FUJI SYNAPSE WORKSTATION SOFTWARE?

FUJI SYNAPSE WORKSTATION SOFTWARE is a medical device that received FDA 510(k) clearance on 2005-07-07. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K051553.

When did FUJI SYNAPSE WORKSTATION SOFTWARE receive FDA 510(k) clearance?

FUJI SYNAPSE WORKSTATION SOFTWARE received FDA 510(k) clearance on 2005-07-07, under 510(k) number K051553.

Who is the listed applicant for FUJI SYNAPSE WORKSTATION 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 FUJI SYNAPSE WORKSTATION SOFTWARE?

The FDA product code for FUJI SYNAPSE WORKSTATION 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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