V5med Lung AI— 510(k) K242919

Substantially Equivalent

V5med, Inc.

FDA 510(k) clearance K242919 for V5med Lung AI, Substantially Equivalent on 2025-03-27. Applicant: V5med, Inc.. Device class: 2.

Clearance details

Applicant: V5med, Inc.
Product code: Code OEB
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-09-24
Decision date: 2025-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu County, TW

Download summary PDF View on FDA.gov ↗

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