Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K895794 |
Device Name |
GE MR MAX SYSTEM |
Applicant |
GE MEDICAL SYSTEMS |
PO BOX 414 |
MILWAUKEE,
WI
53201
|
|
Applicant Contact |
KROGER, PHD |
Correspondent |
GE MEDICAL SYSTEMS |
PO BOX 414 |
MILWAUKEE,
WI
53201
|
|
Correspondent Contact |
KROGER, PHD |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 09/28/1989 |
Decision Date | 11/17/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|