TRUEBEAM


Device Classification Name

accelerator, linear, medical

510(k) Number K111106
Device Name TRUEBEAM
Applicant
VARIAN MEDICAL SYSTEMS, INC.
3100 hansen way
palo alto, 
CA 
94304

Applicant Contact vy tran
Correspondent
VARIAN MEDICAL SYSTEMS, INC.
3100 hansen way
palo alto, 
CA 
94304

Correspodent Contact vy tran
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 04/20/2011
Decision Date 08/18/2011
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