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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 phase-changing fiducial marker for radiation therapy
De Novo Number DEN220017
Device Name BioXmark
Requester
nanovi a/s
diplomvej 378
kgs. lyngby,  DK 2800
Contact hsiao-qing chow
Regulation Number892.5727
Classification Product Code
QUV  
Date Received03/04/2022
Decision Date 12/23/2022
Decision granted (DENG)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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