Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K092639 |
Device Name |
INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP |
Applicant |
GE MEDICAL SYSTEMS SCS |
3000 NORTH GRANDVIEW BLVD |
W450 |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
NICOLE LANDREVILLE |
Correspondent |
GE MEDICAL SYSTEMS SCS |
3000 NORTH GRANDVIEW BLVD |
W450 |
WAUKESHA,
WI
53188
|
|
Correspondent Contact |
NICOLE LANDREVILLE |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 08/27/2009 |
Decision Date | 12/02/2009 |
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
|
|
|