Device Classification Name |
Interventional Fluoroscopic X-Ray System
|
510(k) Number |
K210055 |
Device Name |
Cios Alpha |
Applicant |
Siemens Medical Solutions USA, Inc. |
40 Liberty Boulevard 65-1A |
Malvern,
PA
19355
|
|
Applicant Contact |
Cordell Fields |
Correspondent |
Siemens Medical Solutions USA, Inc. |
40 Liberty Boulevard 65-1A |
Malvern,
PA
19355
|
|
Correspondent Contact |
Cordell Fields |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/08/2021 |
Decision Date | 02/05/2021 |
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
|
|
|