Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K121387 |
Device Name |
CENTRICITY PACS-IW |
Applicant |
GE HEALTHCARE INTEGRATED IT SOLUTIONS |
540 W. NW HIGHWAY |
BARRINGTON,
IL
60010
|
|
Applicant Contact |
JOHN MANARIK |
Correspondent |
GE HEALTHCARE INTEGRATED IT SOLUTIONS |
540 W. NW HIGHWAY |
BARRINGTON,
IL
60010
|
|
Correspondent Contact |
JOHN MANARIK |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 05/08/2012 |
Decision Date | 06/05/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|