Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K152584 |
Device Name |
Stroke VCAR |
Applicant |
GE MEDICAL SYSTEMS SCS |
283 RUE DE LA MINIERE |
BUC,
FR
78530
|
|
Applicant Contact |
Peter Uhlir |
Correspondent |
GE HEALTHCARE |
540 W Northwest Highway |
Barrington,
IL
60010
|
|
Correspondent Contact |
Jeme Wallace |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 09/10/2015 |
Decision Date | 01/20/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|