Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K990426 |
Device Name |
CALCIUM SCORING |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVE. SOUTH |
ISELIN,
NJ
08830
|
|
Applicant Contact |
ALICIA BUSTOS-JUERGENSEN |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVE. SOUTH |
ISELIN,
NJ
08830
|
|
Correspondent Contact |
ALICIA BUSTOS-JUERGENSEN |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 02/11/1999 |
Decision Date | 05/12/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|