Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K152036 |
Device Name |
SOMATOM Definition Edge, SOMATOM Definition AS/AS+ |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
51 VALLEY STREAM PARKWAY |
MALVERN,
PA
19355
|
|
Applicant Contact |
KIMBERLY MANGUM |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
51 VALLEY STREAM PARKWAY |
MALVERN,
PA
19355
|
|
Correspondent Contact |
KIMBERLY MANGUM |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 07/22/2015 |
Decision Date | 10/09/2015 |
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
|
|
|