Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K913563 |
Device Name |
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIY |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVENUE SOUTH |
ISELIN,
NJ
08830
|
|
Applicant Contact |
STEPHEN KEOL |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVENUE SOUTH |
ISELIN,
NJ
08830
|
|
Correspondent Contact |
STEPHEN KEOL |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 08/09/1991 |
Decision Date | 09/11/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|