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FDA 510(k)

Synapse 3D Optional Tools

K-Number: K181773 · 2018-09-25

Decision Date2018-09-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Synapse 3D Optional Tools is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2018-09-25 under approval number K181773. 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 Optional Tools?

Synapse 3D Optional Tools is a medical device that received FDA 510(k) clearance on 2018-09-25. It is manufactured by Fujifilm Corporation. The 510(k) number is K181773.

When was Synapse 3D Optional Tools approved by the FDA?

Synapse 3D Optional Tools received FDA 510(k) clearance on 2018-09-25, under approval number K181773.

What company makes Synapse 3D Optional Tools?

Synapse 3D Optional Tools is manufactured by Fujifilm Corporation.

What is the FDA product code for Synapse 3D Optional Tools?

The FDA product code for Synapse 3D Optional Tools is LLZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.