DIGITAL LIGHTBOX


Device Classification Name

system, image processing, radiological

510(k) Number K080608
Device Name DIGITAL LIGHTBOX
Applicant
BRAINLAB, AG
kapellenstr. 12
feldkirchen, 

DE

85622

Applicant Contact rainer birkenbach
Correspondent
BRAINLAB, AG
kapellenstr. 12
feldkirchen, 

DE

85622

Correspodent Contact rainer birkenbach
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 03/04/2008
Decision Date 04/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No