TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE


Device Classification Name

accelerator, linear, medical

510(k) Number K081188
Device Name TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE
Applicant
VARIAN MEDICAL SYSTEMS, INC.
3100 hansen way m/s e-110
palo alto, 
CA 
94304

Applicant Contact vy tran
Correspondent
VARIAN MEDICAL SYSTEMS, INC.
3100 hansen way m/s e-110
palo alto, 
CA 
94304

Correspodent Contact vy tran
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 04/28/2008
Decision Date 07/14/2008
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