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FDA 510(k)

Synapse 3D Perfusion Analysis

K-Number: K162287 · 2017-04-06

ApplicantFujifilm Medical Systems U.S.A, Inc.
Decision Date2017-04-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Synapse 3D Perfusion Analysis is a medical device manufactured by Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2017-04-06 under approval number K162287. 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 3D Perfusion Analysis?

Synapse 3D Perfusion Analysis is a medical device that received FDA 510(k) clearance on 2017-04-06. It is manufactured by Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K162287.

When was Synapse 3D Perfusion Analysis approved by the FDA?

Synapse 3D Perfusion Analysis received FDA 510(k) clearance on 2017-04-06, under approval number K162287.

What company makes Synapse 3D Perfusion Analysis?

Synapse 3D Perfusion Analysis is manufactured by Fujifilm Medical Systems U.S.A, Inc..

What is the FDA product code for Synapse 3D Perfusion Analysis?

The FDA product code for Synapse 3D Perfusion Analysis 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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