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 K061140
Device Name TRILOGY RADIOTHERAPY DELIVERY SYSTEM
Applicant
VARIAN MEDICAL SYSTEMS
3100 HANSEN WAY
PALO ALTO,  CA  94304 -1129
Applicant Contact VY TRAN
Correspondent
VARIAN MEDICAL SYSTEMS
3100 HANSEN WAY
PALO ALTO,  CA  94304 -1129
Correspondent Contact VY TRAN
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/24/2006
Decision Date 05/15/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-