Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K020573 |
Device Name |
MODIFICATION TO MAGNETOM RHAPSODY SYSTEM |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVENUE SOUTH |
ISELIN,
NJ
08830
|
|
Applicant Contact |
JAMES YIEH |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVENUE SOUTH |
ISELIN,
NJ
08830
|
|
Correspondent Contact |
JAMES YIEH |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 01/28/2002 |
Decision Date | 03/13/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|