Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K151749 |
Device Name |
somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version) |
Applicant |
Siemens Medical Solutions USA, Inc. |
51 Valley Stream Parkway |
Malvern,
PA
19355
|
|
Applicant Contact |
Eve Davis |
Correspondent |
Siemens Medical Solutions USA, Inc. |
40 Liberty Boulevard, mail code 65-1A |
Malvern,
PA
19355
|
|
Correspondent Contact |
Kimberly Mangum |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 06/29/2015 |
Decision Date | 03/18/2016 |
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
|
|
|