CORONIS FUSION 4MP DL


Device Classification Name

system, image processing, radiological

510(k) Number K111989
Device Name CORONIS FUSION 4MP DL
Applicant
BARCO NV
35 president kennedypark
kortrijk, 

BE

8500

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

BE

8500

Correspodent Contact lieven de wandel
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 07/13/2011
Decision Date 09/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No