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 Accelerator, Linear, Medical
510(k) Number K063839
Device Name POSITIONER
Applicant
C-Rad Positioning AB
Kungsangsvagen 29
Uppsala,  SE 75323
Applicant Contact BENGT ERIC ROSTH
Correspondent
C-Rad Positioning AB
Kungsangsvagen 29
Uppsala,  SE 75323
Correspondent Contact BENGT ERIC ROSTH
Regulation Number892.5050
Classification Product Code
IYE  
Date Received12/26/2006
Decision Date 02/08/2007
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
-
-