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

510(k) Premarket Notification
  • 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 System, Planning, Radiation Therapy Treatment
510(k) Number K133655
Device Name RADIANCE V2
Applicant
Gmv Soluciones Globales Internet S.A.U.
Asterweg 19
Amsterdam, Noord Holland,  NL 1031 HL
Applicant Contact ALBERT KOSTER
Correspondent
Gmv Soluciones Globales Internet S.A.U.
Asterweg 19
Amsterdam, Noord Holland,  NL 1031 HL
Correspondent Contact ALBERT KOSTER
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received11/27/2013
Decision Date 01/31/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-