ECLIPSE, HELIOS OPTION


Device Classification Name

system,planning,radiation therapy treatment

510(k) Number K021268
Device Name ECLIPSE, HELIOS OPTION
Original Applicant
VARIAN MEDICAL SYSTEMS, INC.
3100 hansen way
palo alto, 
CA 
94304

Original Contact linda s nash
Regulation Number 892.5050
Classification Product Code
MUJ  
Date Received 04/22/2002
Decision Date 05/22/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No