# K250282: Persona C HR

- Pathway: 510(k) (Traditional)
- Applicant: A.T.S. Applicazione Tecnologie Speciali S.R.L.
- Decided: Apr 30, 2025 after 89 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K182086 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182086: Arco FP, A.T.S. Applicazione Tecnologie Speciali S.R.L. (2019) Summary page 6.

## Indications for use
PERSONA C HR is a mobile X-ray device used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. PERSONA C HR device can be used on all patients, except pediatric patients, within the limits of the device. Examples of clinical applications could be Orthopedic surgery, General surgery, Cardiac procedures, Thoracic surgery, Vascular procedures, Pain therapy and Urological procedures.

Source page: https://510kreport.com/device/K250282
Methodology: https://510kreport.com/methodology