• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name accelerator, linear, medical
510(k) Number K121663
Device Name CLARITY
Original Applicant
ELEKTA LTD.
2050 bleury, suite 200
montreal,  CA h3a 2j5
Original Contact george papagiannis
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Codes
IWB   KPQ  
Date Received06/05/2012
Decision Date 12/05/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-