Device Classification Name |
Interventional Fluoroscopic X-Ray System
|
510(k) Number |
K193326 |
Device Name |
ARTIS Icono |
Applicant |
Siemens Medical Solutions USA, Inc. |
40 Liberty Boulevard 65-1A |
Malvern,
PA
19355
|
|
Applicant Contact |
Patricia D. Jones |
Correspondent |
Siemens Medical Solutions USA, Inc. |
40 Liberty Boulevard 65-1A |
Malvern,
PA
19355
|
|
Correspondent Contact |
Patricia D. Jones |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/02/2019 |
Decision Date | 04/16/2020 |
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
|
|
|