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FDA 510(k)

JiveX (Model Number / Release: 5.4)

K-Number: K231041 · 2023-07-14

ApplicantVisus Health IT GmbH
Decision Date2023-07-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

JiveX (Model Number / Release: 5.4) is a medical device manufactured by Visus Health IT GmbH. It received FDA 510(k) clearance on 2023-07-14 under approval number K231041. 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 JiveX (Model Number / Release: 5.4)?

JiveX (Model Number / Release: 5.4) is a medical device that received FDA 510(k) clearance on 2023-07-14. It is manufactured by Visus Health IT GmbH. The 510(k) number is K231041.

When was JiveX (Model Number / Release: 5.4) approved by the FDA?

JiveX (Model Number / Release: 5.4) received FDA 510(k) clearance on 2023-07-14, under approval number K231041.

What company makes JiveX (Model Number / Release: 5.4)?

JiveX (Model Number / Release: 5.4) is manufactured by Visus Health IT GmbH.

What is the FDA product code for JiveX (Model Number / Release: 5.4)?

The FDA product code for JiveX (Model Number / Release: 5.4) is LLZ.

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Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026)

Other Devices by Visus Health IT GmbH

K181964JiveX K200703JiveX K212321JiveX (Model Number / Release: 5.3)

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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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