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FDA 510(k)

SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0

K-Number: K112439 · 2011-10-17

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date2011-10-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical System U.S.A., Inc.. It received FDA 510(k) clearance on 2011-10-17 under 510(k) number K112439. 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 SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0?

SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0 is a medical device that received FDA 510(k) clearance on 2011-10-17. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K112439.

When did SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0 receive FDA 510(k) clearance?

SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0 received FDA 510(k) clearance on 2011-10-17, under 510(k) number K112439.

Who is the listed applicant for SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0?

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

What is the FDA product code for SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0?

The FDA product code for SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0 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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