Device Classification Name |
Interventional Fluoroscopic X-Ray System
|
510(k) Number |
K052202 |
Device Name |
AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
51 VALLEY STREAM PARKWAY, E-50 |
MALVERN,
PA
19355
|
|
Applicant Contact |
GARY JOHNSON |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
51 VALLEY STREAM PARKWAY, E-50 |
MALVERN,
PA
19355
|
|
Correspondent Contact |
GARY JOHNSON |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/12/2005 |
Decision Date | 03/07/2006 |
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
|
|
|