LVivo Software Application— 510(k) K243862

Name: FDA 510(k) clearance K243862
Creator: U.S. Food and Drug Administration
Published: 2025-03-17

Substantially Equivalent

Dia Imaging Analysis, Ltd.

FDA 510(k) clearance K243862 for LVivo Software Application, Substantially Equivalent on 2025-03-17. Applicant: Dia Imaging Analysis, Ltd.. Device class: 2.

Clearance details

Applicant: Dia Imaging Analysis, Ltd.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-12-16
Decision date: 2025-03-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Beer-Sheva, IL

Download summary PDF View on FDA.gov ↗

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More clearances from Dia Imaging Analysis, Ltd.

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K243331 — LVivo Seamless2025-03-06
K243235 — LVivo Software Application2025-03-03
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K240769 — LVivo IQS2024-05-24
K222970 — LVivo IQS2023-02-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.