K250282 is an FDA 510(k) clearance for the Persona C HR. This device is classified as a Interventional Fluoroscopic X-ray System (Class II - Special Controls, product code OWB).
Submitted by A.T.S. Applicazione Tecnologie Speciali S.R.L. (Torre De' Roveri, IT). The FDA issued a Cleared decision on April 30, 2025, 89 days after receiving the submission on January 31, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K250282 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2025 |
| Decision Date | April 30, 2025 |
| Days to Decision | 89 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 |