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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lung Computed Tomography System, Computer-Aided Detection
510(k) Number K242919
Device Name V5med Lung AI
Applicant
V5med Inc.
7F., No. 36, Chenggong 12th St., Zhubei City
Hsinchu County,  TW 302050
Applicant Contact Ining Cheng
Correspondent
V5med Inc.
7F., No. 36, Chenggong 12th St., Zhubei City
Hsinchu County,  TW 302050
Correspondent Contact Ining Cheng
Regulation Number892.2050
Classification Product Code
OEB  
Subsequent Product Code
LLZ  
Date Received09/24/2024
Decision Date 03/27/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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