Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K113490 |
Device Name |
OPTIMA MR450W |
Applicant |
GE MEDICAL SYSTEMS, LLC |
3000 N GRANDVIEW BLVD. |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
ROBIN MARTIN |
Correspondent |
GE MEDICAL SYSTEMS, LLC |
3000 N GRANDVIEW BLVD. |
WAUKESHA,
WI
53188
|
|
Correspondent Contact |
ROBIN MARTIN |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 11/23/2011 |
Decision Date | 01/13/2012 |
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
|
|
|