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 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
Predetermined Change
Control Plan Authorized		 No
-
-