Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K103411 |
Device Name |
IDEAL IQ SOFTWARE OPTION |
Applicant |
GE MEDICAL SYSTEMS |
3200 N GRANDVIEW BLVD |
W-827 |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
TRACEY FOX |
Correspondent |
GE MEDICAL SYSTEMS |
3200 N GRANDVIEW BLVD |
W-827 |
WAUKESHA,
WI
53188
|
|
Correspondent Contact |
TRACEY FOX |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 11/22/2010 |
Decision Date | 03/22/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|