Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K013922 |
Device Name |
CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM |
Applicant |
BARCO NV |
P.O. BOX 12038 |
LA JOLLA,
CA
92039 -2038
|
|
Applicant Contact |
FRANK FERGUSON |
Correspondent |
BARCO NV |
P.O. BOX 12038 |
LA JOLLA,
CA
92039 -2038
|
|
Correspondent Contact |
FRANK FERGUSON |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 11/27/2001 |
Decision Date | 01/28/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|