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FDA 510(k)

SynthVISION 1.0.0

K-Number: K240724 · 2024-08-08

ApplicantSynthesis Health Intelligence, Inc.
Decision Date2024-08-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SynthVISION 1.0.0 is a medical device manufactured by Synthesis Health Intelligence, Inc.. It received FDA 510(k) clearance on 2024-08-08 under approval number K240724. 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 SynthVISION 1.0.0?

SynthVISION 1.0.0 is a medical device that received FDA 510(k) clearance on 2024-08-08. It is manufactured by Synthesis Health Intelligence, Inc.. The 510(k) number is K240724.

When was SynthVISION 1.0.0 approved by the FDA?

SynthVISION 1.0.0 received FDA 510(k) clearance on 2024-08-08, under approval number K240724.

What company makes SynthVISION 1.0.0?

SynthVISION 1.0.0 is manufactured by Synthesis Health Intelligence, Inc..

What is the FDA product code for SynthVISION 1.0.0?

The FDA product code for SynthVISION 1.0.0 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.

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