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FDA 510(k)

Synapse 3D Cardiac Tools

K-Number: K200973 · 2020-08-27

ApplicantFujifilm Corporaton
Decision Date2020-08-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Synapse 3D Cardiac Tools is a medical device manufactured by Fujifilm Corporaton. It received FDA 510(k) clearance on 2020-08-27 under approval number K200973. 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 Cardiac Tools?

Synapse 3D Cardiac Tools is a medical device that received FDA 510(k) clearance on 2020-08-27. It is manufactured by Fujifilm Corporaton. The 510(k) number is K200973.

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

Synapse 3D Cardiac Tools received FDA 510(k) clearance on 2020-08-27, under approval number K200973.

What company makes Synapse 3D Cardiac Tools?

Synapse 3D Cardiac Tools is manufactured by Fujifilm Corporaton.

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

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

Related Clinical Trials

NCT07545512 ODSSEY-SCD_Identification Of Markers to preDict the rISk of Sudden Cardiac Death in Moderated LVEF in ischEmic cardiomyopathY NOT_YET_RECRUITING

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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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