BARCO MAMMO TOMOSYNTHESIS


Device Classification Name

system, image processing, radiological

510(k) Number K103792
Device Name BARCO MAMMO TOMOSYNTHESIS
Applicant
BARCO NV
35 president kennedypark
8500 kortrijk, 

BE

Applicant Contact lieven de wandel
Correspondent
BARCO NV
35 president kennedypark
8500 kortrijk, 

BE

Correspodent Contact lieven de wandel
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 12/27/2010
Decision Date 03/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No