Device Classification Name |
system, x-ray, stationary
|
510(k) Number |
K121513 |
Device Name |
MULTIX FUSION |
Applicant |
SIEMENS MEDICAL SOLUTION |
51 VALLEY STREAM PKWY. |
MALVERN,
PA
19355
|
|
Applicant Contact |
PATRICIA D JONES |
Correspondent |
SIEMENS MEDICAL SOLUTION |
51 VALLEY STREAM PKWY. |
MALVERN,
PA
19355
|
|
Correspondent Contact |
PATRICIA D JONES |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 05/21/2012 |
Decision Date | 08/10/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|