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 K151666
Device Name Leksell GammaPlan
Applicant
ELEKTA INSTRUMENT AB
KUNGSTENSGATAN 18
STOCKHOLM,  SE 10393
Applicant Contact MATILDA FORSBERG
Correspondent
ELEKTA INSTRUMENT AB
KUNGSTENSGATAN 18
STOCKHOLM,  SE 10393
Correspondent Contact MATILDA FORSBERG
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received06/19/2015
Decision Date 09/03/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-