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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Post-Ablation Tissue Response Prediction Software
510(k) Number K243084
Device Name BioTraceIO Precision (2.0)
Applicant
Techsomed Medical Technologies , Ltd.
Meir Weisgal 2
Rehovot,  IL 7654055
Applicant Contact Dalia Dickman
Correspondent
Techsomed Medical Technologies , Ltd.
Meir Weisgal 2
Rehovot,  IL 7654055
Correspondent Contact Dalia Dickman
Classification Product Code
QZL  
Date Received09/30/2024
Decision Date 12/27/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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