The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Artis Icono (ve21) System.
| Device ID | K220432 |
| 510k Number | K220432 |
| Device Name: | ARTIS Icono (VE21) System |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 |
| Contact | Patricia D. Jones |
| Correspondent | Patricia D. Jones Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 |
| Product Code | OWB |
| Subsequent Product Code | IZI |
| Subsequent Product Code | JAA |
| Subsequent Product Code | JAK |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-15 |
| Decision Date | 2022-06-29 |