Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K112570 |
Device Name |
CENTRICITY CARDIO IMAGING |
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 | 09/06/2011 |
Decision Date | 11/30/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|