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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 Ablation Therapy Planning And Evaluation
510(k) Number K251931
Device Name BioTraceIO Vision (V1.7)
Applicant
Techsomed Medical Technologies
6 Ofra Haza St.
Or Yehuda,  IL 6032303
Applicant Contact Dalia Dickman
Correspondent
Techsomed Medical Technologies
6 Ofra Haza St.
Or Yehuda,  IL 6032303
Correspondent Contact Dalia Dickman
Regulation Number892.2050
Classification Product Code
QTZ  
Subsequent Product Codes
LLZ   QIH  
Date Received06/24/2025
Decision Date 09/08/2025
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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