NIO 5MP


Device Classification Name

system, image processing, radiological

510(k) Number K121788
Device Name NIO 5MP
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 06/18/2012
Decision Date 07/23/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No