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FDA 510(k)

LVivo Software Application

K-Number: K210053 · 2021-02-05

ApplicantDia Imaging Analysis, Ltd.
Decision Date2021-02-05
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 2021-02-05 under approval number K210053. 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 2021-02-05. It is manufactured by Dia Imaging Analysis, Ltd.. The 510(k) number is K210053.

When was LVivo Software Application approved by the FDA?

LVivo Software Application received FDA 510(k) clearance on 2021-02-05, under approval number K210053.

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: 39698124 Advancements in Clinical Evaluation and Regulatory Frameworks for AI-Driven Software as a Medical Device (SaMD). IEEE open journal of engineering in medicine and biology (2025) PMID: 25644202 Regulatory frameworks for mobile medical applications. Expert review of medical devices (2015)

Other Devices by Dia Imaging Analysis, Ltd.

K202546LVivo Seamless K200232LVivo Software Application K212466LVivo Seamless K222970LVivo IQS K240553LVivo Software Application K240769LVivo IQS

View all 10 devices →

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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