CORONIS 5MP MAMMO SL, MODEL MDMG 6121


Device Classification Name

system, image processing, radiological

510(k) Number K081109
Device Name CORONIS 5MP MAMMO SL, MODEL MDMG 6121
Applicant
BARCOVIEW, MEDICAL IMAGING SYSTEMS
35 president kennedypark
kortrijk, 

BE

b-8500

Applicant Contact neil phillips
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 04/18/2008
Decision Date 05/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party Yes

Combination Product

No