IPLAN RT IMAGE


Device Classification Name

system, radiation therapy, charged-particle, medical

510(k) Number K080886
Device Name IPLAN RT IMAGE
Applicant
BRAINLAB AG
kapellenstrasse 12
feldkirchen, 

DE

85622

Applicant Contact rainer birkenbach
Correspondent
BRAINLAB AG
kapellenstrasse 12
feldkirchen, 

DE

85622

Correspodent Contact rainer birkenbach
Regulation Number 892.5050
Classification Product Code
LHN  
Date Received 03/31/2008
Decision Date 06/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No