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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name post-ablation tissue response prediction software
De Novo Number DEN230020
Device Name BioTraceIO Lite
Requester
techsomed medical technologies , ltd.
meir weisgal 2
rehovot,  IL 7654055
Contact dalia dickman
Regulation Number892.2052
Classification Product Code
QZL  
Date Received03/30/2023
Decision Date 12/22/2023
Decision granted (DENG)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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