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FDA 510(k)

LVivo Software Application

K-Number: K161382 · 2016-07-28

ApplicantDiacardio, Ltd.
Decision Date2016-07-28
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LVivo Software Application is a medical device manufactured by Diacardio, Ltd.. It received FDA 510(k) clearance on 2016-07-28 under approval number K161382. 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 LVivo Software Application?

LVivo Software Application is a medical device that received FDA 510(k) clearance on 2016-07-28. It is manufactured by Diacardio, Ltd.. The 510(k) number is K161382.

When was LVivo Software Application approved by the FDA?

LVivo Software Application received FDA 510(k) clearance on 2016-07-28, under approval number K161382.

What company makes LVivo Software Application?

LVivo Software Application is manufactured by Diacardio, Ltd..

What is the FDA product code for LVivo Software Application?

The FDA product code for LVivo Software Application is LLZ.

Related Clinical Trials

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Related PubMed Literature

PMID: 41448921 [Research on Standardized Testing Processes and Methods of Graphics Measurement Functions of Medical Device Software]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) PMID: 41116086 Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD). GeroScience (2025)

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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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