Persona C HR
A.T.S. Applicazione Tecnologie Speciali s.r.l.Persona C HR is a mobile C-arm X-ray device used to provide real-time fluoroscopic imaging guidance during various diagnostic, interventional, and surgical procedures. It helps clinicians visualize patient anatomy with high-quality images to assist in precise and effective treatment, excluding pediatric patients.
Intended Use
PERSONA C HR is a mobile X-ray device used for radiological guidance and visualization during diagnostic, interventional and surgical procedures.
Technology
The device employs a flat panel detector and an X-ray tube (up to 25kW) producing X-rays passing through the patient, which are detected and processed by a video processor to display radiological images on a monitor. It includes modes like low dose and high-quality fluoroscopy and digital radiography with an updated amorphous silicon flat panel detector for improved image speed and quality.
Performance
Non-clinical performance testing demonstrates compliance with recognized standards including IEC and FDA guidelines. The device was validated through engineering-based testing including image quality assessment using phantoms and cadaver images by a radiologist. Verification and validation confirmed it is as safe and effective as the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/31/2025
2 months - 2
FDA Approval
4/30/2025
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