Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K063628 |
Device Name |
CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY |
Applicant |
GE HEALTHCARE INTEGRATED IT SOLUTIONS |
540 W. NW HIGHWAY |
BARRINGTON,
IL
60010
|
|
Applicant Contact |
KAREN M LUNDE |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
SILVIA ANKOVA |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 12/06/2006 |
Decision Date | 12/26/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|