• 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 neurological stereotaxic instrument
510(k) Number K190887
Device Name Leksell Vantage Stereotactic System
Elekta Instrument AB
Kungstensgatan 18
Stockholm,  SE 10393
Applicant Contact Helena Skar
Elekta Instrument AB
Kungstensgatan 18
Stockholm,  SE 10393
Correspondent Contact Alf Laurell
Regulation Number882.4560
Classification Product Code
Date Received04/04/2019
Decision Date 08/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls