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 K210500
Device Name Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
Applicant
Elekta Limited
Linac House
Fleming Way
Crawley,  GB RH10 9RR
Applicant Contact Lorenzo Muratori
Correspondent
Elekta, Inc.
Linac House, Fleming Way,
Crawley, W. Sussex,Rh10 9rr
GB
Correspondent Contact Lorenzo Muratori
Regulation Number892.5050
Classification Product Code
IYE  
Date Received02/22/2021
Decision Date 06/11/2021
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
-
-