FDA 510(k)

Synapse Enterprise Viewer Version 1.0

K-Number: K183248 · 2019-04-25

Decision Date2019-04-25

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Synapse Enterprise Viewer Version 1.0 is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2019-04-25 under approval number K183248. 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 Enterprise Viewer Version 1.0?

Synapse Enterprise Viewer Version 1.0 is a medical device that received FDA 510(k) clearance on 2019-04-25. It is manufactured by Fujifilm Corporation. The 510(k) number is K183248.

When was Synapse Enterprise Viewer Version 1.0 approved by the FDA?

Synapse Enterprise Viewer Version 1.0 received FDA 510(k) clearance on 2019-04-25, under approval number K183248.

What company makes Synapse Enterprise Viewer Version 1.0?

Synapse Enterprise Viewer Version 1.0 is manufactured by Fujifilm Corporation.

What is the FDA product code for Synapse Enterprise Viewer Version 1.0?

The FDA product code for Synapse Enterprise Viewer Version 1.0 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.