Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K971684 |
Device Name |
MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE) |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVE. SOUTH |
ISELIN,
NJ
08830
|
|
Applicant Contact |
KATHLEEN RUTHERFORD |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVE. SOUTH |
ISELIN,
NJ
08830
|
|
Correspondent Contact |
KATHLEEN RUTHERFORD |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 05/07/1997 |
Decision Date | 08/05/1997 |
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
|
|
|