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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 fludeoxyglucose f18-guided radiation therapy system
De Novo Number DEN220014
Device Name RefleXion Medical Radiotherapy System (RMRS)
Requester
RefleXion Medical Inc
25841 industrial boulevard, suite 275
hayward,  CA  94545
Contact kathy o'shaughnessy
Regulation Number892.5060
Classification Product Code
QVA  
Date Received02/23/2022
Decision Date 02/01/2023
Decision granted (DENG)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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