Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K093234 |
Device Name |
INTEGRATED REGISTRATION |
Applicant |
GE MEDICAL SYSTEMS SCS |
283 RUE DE LA MINIERE BP 34 |
BUC CEDEX,
FR
78533
|
|
Applicant Contact |
SOPHIE LE LOARER |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DANIEL W LEHTONEN |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 10/15/2009 |
Decision Date | 10/30/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|