Device Classification Name |
system, x-ray, fluoroscopic, image-intensified
|
510(k) Number |
K051602 |
Device Name |
AXIOM SIRESKOP SD |
Applicant |
SIEMENS MEDICAL SYSTEMS, INC. |
51 VALLEY STREAM PARKWAY |
MALVERN,
PA
19355 -1406
|
|
Applicant Contact |
GARY JOHNSON |
Correspondent |
SIEMENS MEDICAL SYSTEMS, INC. |
51 VALLEY STREAM PARKWAY |
MALVERN,
PA
19355 -1406
|
|
Correspondent Contact |
GARY JOHNSON |
Regulation Number | 892.1650
|
Classification Product Code |
|
Date Received | 06/16/2005 |
Decision Date | 07/07/2005 |
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
|
|
|