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FDA 510(k)

Synapse 3D Blood Flow Analysis

K-Number: K191544 · 2019-10-18

ApplicantFujifilm Corporation
Decision Date2019-10-18
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Synapse 3D Blood Flow Analysis is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2019-10-18 under approval number K191544. 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 Blood Flow Analysis?

Synapse 3D Blood Flow Analysis is a medical device that received FDA 510(k) clearance on 2019-10-18. It is manufactured by Fujifilm Corporation. The 510(k) number is K191544.

When was Synapse 3D Blood Flow Analysis approved by the FDA?

Synapse 3D Blood Flow Analysis received FDA 510(k) clearance on 2019-10-18, under approval number K191544.

What company makes Synapse 3D Blood Flow Analysis?

Synapse 3D Blood Flow Analysis is manufactured by Fujifilm Corporation.

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

The FDA product code for Synapse 3D Blood Flow 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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