Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K160618 |
Device Name |
Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T |
Applicant |
GE MEDICAL SYSTEMS, LLC |
3200 N. GRANDVIEW BLVD. |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
Jason Ma |
Correspondent |
GE MEDICAL SYSTEMS, LLC |
3200 N. GRANDVIEW BLVD. |
WAUKESHA,
WI
53188
|
|
Correspondent Contact |
Jason Ma |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 03/03/2016 |
Decision Date | 06/09/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|