Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K992746 |
Device Name |
SIGNA HFO/I MAGNETIC RESONANCE SYSTEM |
Applicant |
GE MEDICAL SYSTEMS, INC. |
P.O. BOX 414 |
MILWAUKEE,
WI
53201
|
|
Applicant Contact |
LARRY A KROGER |
Correspondent |
GE MEDICAL SYSTEMS, INC. |
P.O. BOX 414 |
MILWAUKEE,
WI
53201
|
|
Correspondent Contact |
LARRY A KROGER |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 08/16/1999 |
Decision Date | 11/09/1999 |
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
|
|
|