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FDA 510(k)

LVivo Software Application

K-Number: K243235 · 2025-03-03

ApplicantDia Imaging Analysis, Ltd.
Decision Date2025-03-03
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LVivo Software Application is the device name listed in this FDA 510(k) record. The listed applicant is Dia Imaging Analysis, Ltd.. It received FDA 510(k) clearance on 2025-03-03 under 510(k) number K243235. 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 2025-03-03. The listed applicant is Dia Imaging Analysis, Ltd.. The 510(k) number is K243235.

When did LVivo Software Application receive FDA 510(k) clearance?

LVivo Software Application received FDA 510(k) clearance on 2025-03-03, under 510(k) number K243235.

Who is the listed applicant for LVivo Software Application?

The FDA 510(k) record lists Dia Imaging Analysis, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LVivo Software Application?

The FDA product code for LVivo Software Application is QIH.

Other records listing Dia Imaging Analysis, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243862LVivo Software ApplicationK243331LVivo SeamlessK240553LVivo Software ApplicationK240769LVivo IQSK222970LVivo IQSK212466LVivo Seamless

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Related Devices (Code: QIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253794Prostate CoreLucida Medical, Ltd.K252571mdprostateMediaire GmbHK253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, 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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