The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Cios Select (va21) Image Intensifier.
| Device ID | K210307 |
| 510k Number | K210307 |
| Device Name: | Cios Select (VA21) Image Intensifier |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard 65-1A Malvern, PA 19355 |
| Contact | Cordell Fields |
| Correspondent | Cordell Fields Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard 65-1A 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 | 2021-02-03 |
| Decision Date | 2021-03-04 |