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 |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
12 LABORATORY DR. |
RESEARCH TRIANGLE,
NC
27709
|
|
Correspondent Contact |
JEFF D RONGERO |
Regulation Number | 892.2050
|
Classification Product Code |
|
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
|
|
|