Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K042221 |
Device Name |
CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM |
Applicant |
BARCO NV BARCOVIEW |
12200 ACADEMY ROAD NE |
# 931 |
ALBUQUERQUE,
NM
87111
|
|
Applicant Contact |
FRANK FERGUSON |
Correspondent |
BARCO NV BARCOVIEW |
12200 ACADEMY ROAD NE |
# 931 |
ALBUQUERQUE,
NM
87111
|
|
Correspondent Contact |
FRANK FERGUSON |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 08/17/2004 |
Decision Date | 12/30/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|