Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K964747 |
Device Name |
SOMATOM PLUS 4 CT SCANNER |
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 | 892.1750
|
Classification Product Code |
|
Date Received | 11/26/1996 |
Decision Date | 02/10/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|