TOMOTHERAPY TREATMENT SYSTEM


Device Classification Name

system,planning,radiation therapy treatment

510(k) Number K112446
Device Name TOMOTHERAPY TREATMENT SYSTEM
Applicant
TOMOTHERAPY INCORPORATED
1209 deming way
madison, 
WI 
53717

Applicant Contact greg bange
Correspondent
TOMOTHERAPY INCORPORATED
1209 deming way
madison, 
WI 
53717

Correspodent Contact greg bange
Regulation Number 892.5050
Classification Product Code
MUJ  
Date Received 08/24/2011
Decision Date 10/07/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No