Device Classification Name |
System, X-Ray, Fluoroscopic, Image-Intensified
|
510(k) Number |
K021021 |
Device Name |
MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVENUE SOUTH |
ISELIN,
NJ
08830
|
|
Applicant Contact |
SANDRA ROBINSON |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVENUE SOUTH |
ISELIN,
NJ
08830
|
|
Correspondent Contact |
SANDRA ROBINSON |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/29/2002 |
Decision Date | 06/06/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|