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FDA 510(k)

LVivo Software Application

K-Number: K200232 · 2020-06-23

ApplicantDia Imaging Analysis, Ltd.
Decision Date2020-06-23
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LVivo Software Application is a medical device manufactured by Dia Imaging Analysis, Ltd.. It received FDA 510(k) clearance on 2020-06-23 under approval number K200232. The device is classified under product code QIH. 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 2020-06-23. It is manufactured by Dia Imaging Analysis, Ltd.. The 510(k) number is K200232.

When was LVivo Software Application approved by the FDA?

LVivo Software Application received FDA 510(k) clearance on 2020-06-23, under approval number K200232.

What company makes LVivo Software Application?

LVivo Software Application is manufactured by Dia Imaging Analysis, Ltd..

What is the FDA product code for LVivo Software Application?

The FDA product code for LVivo Software Application is QIH.

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)

Other Devices by Dia Imaging Analysis, Ltd.

K202546LVivo Seamless K212466LVivo Seamless K210053LVivo Software Application K222970LVivo IQS K240553LVivo Software Application K240769LVivo IQS

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Related Devices (Code: QIH)

K191647QLAB Advanced Quantification SoftwarePhilips Health Care K191171EchoGo CoreUltromics, Ltd. K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc. K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc. K202546LVivo SeamlessDia Imaging Analysis, Ltd. K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.

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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