The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Cios Select (va21) Flat Panel.
| Device ID | K223410 |
| 510k Number | K223410 |
| Device Name: | Cios Select (VA21) Flat Panel |
| 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 | JAA |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-11-09 |
| Decision Date | 2022-12-07 |