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FDA 510(k)

Synapse 3D, Synapse 3D Base Tools v6.1

K-Number: K203103 · 2021-02-09

ApplicantFujifilm Corporation
Decision Date2021-02-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Synapse 3D, Synapse 3D Base Tools v6.1 is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2021-02-09 under approval number K203103. 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, Synapse 3D Base Tools v6.1?

Synapse 3D, Synapse 3D Base Tools v6.1 is a medical device that received FDA 510(k) clearance on 2021-02-09. It is manufactured by Fujifilm Corporation. The 510(k) number is K203103.

When was Synapse 3D, Synapse 3D Base Tools v6.1 approved by the FDA?

Synapse 3D, Synapse 3D Base Tools v6.1 received FDA 510(k) clearance on 2021-02-09, under approval number K203103.

What company makes Synapse 3D, Synapse 3D Base Tools v6.1?

Synapse 3D, Synapse 3D Base Tools v6.1 is manufactured by Fujifilm Corporation.

What is the FDA product code for Synapse 3D, Synapse 3D Base Tools v6.1?

The FDA product code for Synapse 3D, Synapse 3D Base Tools v6.1 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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