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 the device name listed in this FDA 510(k) record. The listed applicant is Synthesis Health Intelligence, Inc.. It received FDA 510(k) clearance on 2024-08-08 under 510(k) 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. The listed applicant is Synthesis Health Intelligence, Inc.. The 510(k) number is K240724.

When did SynthVISION 1.0.0 receive FDA 510(k) clearance?

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

Who is the listed applicant for SynthVISION 1.0.0?

The FDA 510(k) record lists Synthesis Health Intelligence, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SynthVISION 1.0.0?

The FDA product code for SynthVISION 1.0.0 is LLZ.

Related Devices (Code: 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.