Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K163331 |
Device Name |
Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist |
Applicant |
GE Medical Systems, LLC |
3200 Grandview Blvd |
Waukesha,
WI
53188
|
|
Applicant Contact |
Mary A. Mayka |
Correspondent |
GE Medical Systems, LLC |
3200 Grandview Blvd |
Waukesha,
WI
53188
|
|
Correspondent Contact |
Mary A. Mayka |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 11/28/2016 |
Decision Date | 03/17/2017 |
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
|
|
|