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 K121328
Device Name AGILITY
Applicant
ELEKTA LTD.
FLEMING WAY
LINAC HOUSE
CRAWLEY, WEST SUSSEX,  GB RH10 9RR
Applicant Contact Patrick Hull
Correspondent
ELEKTA LTD.
FLEMING WAY
LINAC HOUSE
CRAWLEY, WEST SUSSEX,  GB RH10 9RR
Correspondent Contact Patrick Hull
Regulation Number892.5050
Classification Product Code
IYE  
Date Received05/03/2012
Decision Date 06/12/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-