EXACTRAC VERO


Device Classification Name

accelerator, linear, medical

510(k) Number K122451
Device Name EXACTRAC VERO
Applicant
BRAINLAB AG
kapellenstrasse 12
feldkirchen, 

DE

85622

Applicant Contact alexander schwiersch
Correspondent
BRAINLAB AG
kapellenstrasse 12
feldkirchen, 

DE

85622

Correspodent Contact alexander schwiersch
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 08/13/2012
Decision Date 09/28/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No