Persona C HR

The Persona C HR is a mobile C-arm fluoroscopic X-ray system used for radiological guidance and visualization during diagnostic, interventional, and surgical procedures. It can be used on all patients except pediatric patients and is applicable to orthopedic surgery, general surgery, cardiac procedures, thoracic surgery, vascular procedures, pain therapy, and urological procedures.

The Persona C HR features a 30×30 cm flat panel aSI-IGZO detector (versus aSi in the predicate), a 25 kW X-ray generator (versus 5–20 kW in the predicate), active cooling of the monobloc (versus passive cooling), a single 32-inch monitor (versus two 21.5-inch monitors), and a 13-inch control panel (versus 12-inch). The new aSI-IGZO detector enables up to 30 fps at full resolution. Software architecture and fundamental operating principles remain substantially equivalent.

Testing complies with ANSI AAMI ES60601-1:2005/(R)2012, IEC 60601-1-2 Edition 4.1 2020-09, IEC 60601-1-3 Edition 2.2 2021-01, IEC 60601-1-6 Edition 3.2 2020-07, IEC 60601-2-43 Edition 3.0 2022-12, and IEC 60601-2-54 Edition 2.0 2022-09. Additionally, the submission addresses FDA guidance on cybersecurity in medical devices and device software functions.

The proposed device is substantially equivalent because it maintains the same fundamental control mechanism, operating principle, energy type (X-rays), and intended use as the predicate ARCO FP (K182086). Although modifications include a higher-capacity generator, improved detector technology, and revised monitor configuration, these changes do not alter the core scientific and technical operation. The manufacturer demonstrated through non-clinical testing that the Persona C HR performs as safely and effectively as the predicate, with image quality validated by radiologists using test phantoms and cadaver images. All differences are characterized as technological evolution that does not raise new safety or effectiveness concerns.