Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K033504 |
Device Name |
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM |
Applicant |
GENERAL ELECTRIC CO. |
P.O. BOX 414 |
MILWAUKEE,
WI
53201
|
|
Applicant Contact |
LARRY A KROGER, PH.D. |
Correspondent |
GENERAL ELECTRIC CO. |
P.O. BOX 414 |
MILWAUKEE,
WI
53201
|
|
Correspondent Contact |
LARRY A KROGER, PH.D. |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 11/05/2003 |
Decision Date | 11/25/2003 |
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
|
|
|