Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K123596 |
Device Name |
OPTIMA CT520 |
Applicant |
GE HANGWEI MEDICAL SYSTEMS CO., LTD. |
NO. 2 N. YONGCHANG STREET |
BEIJING ECONOMIC & TECHNOLOGICAL DEVELOPMENT AREA |
BEIJING,
CN
100176
|
|
Applicant Contact |
HELEN PENG |
Correspondent |
GE HANGWEI MEDICAL SYSTEMS CO., LTD. |
NO. 2 N. YONGCHANG STREET |
BEIJING ECONOMIC & TECHNOLOGICAL DEVELOPMENT AREA |
BEIJING,
CN
100176
|
|
Correspondent Contact |
HELEN PENG |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 11/21/2012 |
Decision Date | 02/08/2013 |
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
|
|
|