Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K110573 |
Device Name |
READY VIEW |
Applicant |
GE HEALTHCARE (GE MEDICAL SYSTEMS SCS) |
3200 N GRANDVIEW BLVD, |
W-827 |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
ELIZABETH MATHEW |
Correspondent |
GE HEALTHCARE (GE MEDICAL SYSTEMS SCS) |
3200 N GRANDVIEW BLVD, |
W-827 |
WAUKESHA,
WI
53188
|
|
Correspondent Contact |
ELIZABETH MATHEW |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 03/01/2011 |
Decision Date | 05/03/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|