Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K061372 |
Device Name |
CENTRICITY AW SUITE OPTION |
Applicant |
GE HEALTHCARE INFORMATION TECHNOLOGIES |
540 W. NW HIGHWAY |
BARRINGTON,
IL
60010
|
|
Applicant Contact |
RHODA VALERA |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
455 E. TRIMBLE ROAD |
SAN JOSE,
CA
95131 -1230
|
|
Correspondent Contact |
ELIZABETH DREW |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 05/17/2006 |
Decision Date | 05/30/2006 |
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
|
|
|