Device Classification Name |
Interventional Fluoroscopic X-Ray System
|
510(k) Number |
K113403 |
Device Name |
GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM |
Applicant |
GE MEDICAL SYSTEMS SCS |
283 RUE DE LA MINIERE |
BUC,
FR
78530
|
|
Applicant Contact |
MICHEL GENUER |
Correspondent |
GE MEDICAL SYSTEMS SCS |
283 RUE DE LA MINIERE |
BUC,
FR
78530
|
|
Correspondent Contact |
MICHEL GENUER |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/17/2011 |
Decision Date | 02/14/2012 |
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
|
|
|