Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K990550 |
Device Name |
3.0T SIGNA VH/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 | 02/22/1999 |
Decision Date | 05/11/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|