Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
-
-