MODEIFICATION TO IPLAN RT DOSE


Device Classification Name

system,planning,radiation therapy treatment

510(k) Number K080888
Device Name MODEIFICATION TO IPLAN RT DOSE
Applicant
BRAINLAB AG
kapellenstrasse 12
feldkirchen, 

DE

85622

Applicant Contact carsten raupach
Correspondent
BRAINLAB AG
kapellenstrasse 12
feldkirchen, 

DE

85622

Correspodent Contact carsten raupach
Regulation Number 892.5050
Classification Product Code
MUJ  
Date Received 03/31/2008
Decision Date 06/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls