Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K150745 |
Device Name |
syngo.CT Single Source Dual Energy |
Applicant |
Siemens Medical Solutions USA, Inc. |
51 Valley Stream Parkway |
Malvem,
PA
19355
|
|
Applicant Contact |
Kimberly Mangum |
Correspondent |
Siemens Medical Solutions USA, Inc. |
51 Valley Stream Parkway |
Malvem,
PA
19355
|
|
Correspondent Contact |
Kimberly Mangum |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 03/23/2015 |
Decision Date | 08/11/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|