K250282
- 510(k) number
- K250282
- Device name
- Persona C HR
- Applicant
- A.T.S. Applicazione Tecnologie Speciali S.R.L. IT
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2025-04-30
- Date received
- 2025-01-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 7.1 MB · U.S. public domain
Also available from FDA: K250282.pdf
Official FDA record: K250282
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.