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 K140187
Device Name RAY STATION
Applicant
Raysearch Laboratories AB
Sveavagen 25, Plan 9
Stockholm,  SE SE-111 34
Applicant Contact LADAN AMIRI
Correspondent
Raysearch Laboratories AB
Sveavagen 25, Plan 9
Stockholm,  SE SE-111 34
Correspondent Contact LADAN AMIRI
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received01/24/2014
Decision Date 05/15/2014
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
Recalls CDRH Recalls
-
-