Cleared Traditional

V5med Lung AI

K242919 · V5med, Inc. · Radiology

Mar 2025

Decision

184d

Days

Class 2

Risk

About This 510(k) Submission

K242919 is an FDA 510(k) clearance for the V5med Lung AI, a Lung Computed Tomography System, Computer-aided Detection (Class II — Special Controls, product code OEB), submitted by V5med, Inc. (Hsinchu County, TW). The FDA issued a Cleared decision on March 27, 2025, 184 days after receiving the submission on September 24, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K242919 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 24, 2024
Decision Date	March 27, 2025
Days to Decision	184 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OEB — Lung Computed Tomography System, Computer-aided Detection
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.2050
Definition	To Assist Radiologists In The Review Of Multi-slice Computed Tomography (msct) Exams Of The Chest And Highlight Potential Nodules That The Radiologist Should Review. A Computer Aided Diagnosis, Lung Computed Tomography System Is A Class 3 Device Under Product Code Nrr.