Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K122471 |
Device Name |
SOMATOM DEFINITION |
Applicant |
SIEMENS MEDICAL SYSTEMS, INC. |
51 VALLEY STREAM PARKWAY |
MALVERN,
PA
19355 -1406
|
|
Applicant Contact |
KIMBERLY MANGUN |
Correspondent |
SIEMENS MEDICAL SYSTEMS, INC. |
51 VALLEY STREAM PARKWAY |
MALVERN,
PA
19355 -1406
|
|
Correspondent Contact |
KIMBERLY MANGUN |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 08/14/2012 |
Decision Date | 09/11/2012 |
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
|
|
|