FDA 510(k)

Synapse 3D Base Tools (V7.0)

K-Number: K243762 · 2025-05-21

Decision Date2025-05-21

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Synapse 3D Base Tools (V7.0) is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2025-05-21 under approval number K243762. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Synapse 3D Base Tools (V7.0)?

Synapse 3D Base Tools (V7.0) is a medical device that received FDA 510(k) clearance on 2025-05-21. It is manufactured by Fujifilm Corporation. The 510(k) number is K243762.

When was Synapse 3D Base Tools (V7.0) approved by the FDA?

Synapse 3D Base Tools (V7.0) received FDA 510(k) clearance on 2025-05-21, under approval number K243762.

What company makes Synapse 3D Base Tools (V7.0)?

Synapse 3D Base Tools (V7.0) is manufactured by Fujifilm Corporation.

What is the FDA product code for Synapse 3D Base Tools (V7.0)?

The FDA product code for Synapse 3D Base Tools (V7.0) is QIH.

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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.