• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name accelerator, linear, medical
510(k) Number K121845
Model SDX
Device Name SDX SYSTEM
Original Applicant
DYN'R SAS
74 cours gambetta
aix en provence,  FR 13100
Original Contact tim lawton
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
LHN  
Date Received06/25/2012
Decision Date 10/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-