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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Image Processing Software For Radiation Therapy
510(k) Number K250427
Device Name TAIMedImg DeepMets
Applicant
Taiwan Medical Imaging Co., Ltd.
3F., No. 1, Fuxing 4th Rd., Qianzhen Dist.,
Kaohsiung City,  TW 806611
Applicant Contact Bo-Ru Lin
Correspondent
Taiwan Medical Imaging Co., Ltd.
3F., No. 1, Fuxing 4th Rd., Qianzhen Dist.,
Kaohsiung City,  TW 806611
Correspondent Contact Paul Chang
Regulation Number892.2050
Classification Product Code
QKB  
Subsequent Product Code
QIH  
Date Received02/14/2025
Decision Date 05/28/2025
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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