Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K153003 |
Device Name |
SIGNA Pioneer |
Applicant |
GE HEALTHCARE |
3200 N. Grandview Blvd. |
Waukesha,
WI
53188
|
|
Applicant Contact |
Andrew Menden |
Correspondent |
GE HEALTHCARE |
3200 N. Grandview Blvd. |
Waukesha,
WI
53188
|
|
Correspondent Contact |
Andrew Menden |
Regulation Number | 892.1000
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/13/2015 |
Decision Date | 10/27/2015 |
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
|
|
|