Submission Details
| 510(k) Number | K250241 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 27, 2025 |
| Decision Date | November 04, 2025 |
| Days to Decision | 281 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
K250241 is an FDA 510(k) clearance for the Cios Select, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Siemens Medical Solutions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on November 4, 2025, 281 days after receiving the submission on January 27, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.
| 510(k) Number | K250241 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 27, 2025 |
| Decision Date | November 04, 2025 |
| Days to Decision | 281 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OWB — Interventional Fluoroscopic X-ray System |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1650 |
| Definition | Interventional Fluoroscopy |