Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K001747 |
Device Name |
MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM |
Applicant |
BARCO NV DISPLAY SYSTEMS |
8524 VILA LA JOLLA DR. |
SUITE 161 |
LA JOLLA,
CA
92037
|
|
Applicant Contact |
FRANK FERGUSON |
Correspondent |
BARCO NV DISPLAY SYSTEMS |
8524 VILA LA JOLLA DR. |
SUITE 161 |
LA JOLLA,
CA
92037
|
|
Correspondent Contact |
FRANK FERGUSON |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 06/08/2000 |
Decision Date | 07/13/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|