Device Classification Name |
interventional fluoroscopic x-ray system
|
510(k) Number |
K230949 |
Device Name |
ARTIS pheno (VE30A) |
Applicant |
Siemens Medical Solutions USA, Inc. |
40 Liberty Boulevard |
Malvern,
PA
19355
|
|
Applicant Contact |
Patricia D. Jones |
Correspondent |
Siemens Medical Solutions USA, Inc. |
40 Liberty Boulevard |
Malvern,
PA
19355
|
|
Correspondent Contact |
Patricia D. Jones |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/04/2023 |
Decision Date | 12/15/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|