Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K070726 |
Device Name |
NIO COLOR 3MP AND MDNC 3120 |
Applicant |
BARCOVIEW, MEDICAL IMAGING SYSTEMS |
35 PRESIDENT KENNEDYPARK |
KORTRIJK,
BE
B-8500
|
|
Applicant Contact |
LIEVEN DE WANDEL |
Correspondent |
BARCOVIEW, MEDICAL IMAGING SYSTEMS |
35 PRESIDENT KENNEDYPARK |
KORTRIJK,
BE
B-8500
|
|
Correspondent Contact |
LIEVEN DE WANDEL |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 03/15/2007 |
Decision Date | 05/02/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|