Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K103480 |
FOIA Releasable 510(k) |
K103480
|
Device Name |
THORACIC VCAR |
Applicant |
GE MEDICAL SYSTEMS, LLC |
3000 N GRANDVIEW |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
STEPHEN SLAVENS |
Correspondent |
GE MEDICAL SYSTEMS, LLC |
3000 N GRANDVIEW |
WAUKESHA,
WI
53188
|
|
Correspondent Contact |
STEPHEN SLAVENS |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 11/26/2010 |
Decision Date | 03/07/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|