Cios Alpha; Cios Flow

The Cios Alpha and Cios Flow are mobile fluoroscopic C-arm X-ray systems designed to provide real-time X-ray imaging during surgical and interventional procedures. They support applications including orthopedic, vascular, cardiac, gastrointestinal, urologic, neurologic, and pain management procedures, and may be used with pediatric patients.

The subject devices (VA31A) incorporate software updated from VA30, an extended NXS interface for InstantLink communication, an updated collimator, a new optional flat-panel detector using IGZO technology (versus amorphous silicon in the predicate), upgraded imaging and graphics processing hardware, and a replacement power supply (Eaton UPS 5P 850i G2). These changes support enhanced functionality while maintaining the same fundamental C-arm geometry and X-ray generation principles.

Compliance verified against IEC 60601-1 (general electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-2-43 (interventional X-ray equipment safety), IEC 60601-2-54 (radiography/radioscopy equipment), IEC 62304 (medical device software lifecycle), ISO 14971 (risk management), IEC 62366-1 (usability), and DICOM PS 3.1–3.20 (medical imaging standards), among others.

The subject devices maintain the same intended use, indications, fundamental operating principle, and C-arm geometry as the predicates (Cios Alpha VA30 and Cios Flow VA30). All hardware and software modifications—including the new detector, updated processors, and software enhancements—were subjected to verification and validation testing that met acceptance criteria and raised no new safety or effectiveness concerns. A clinical cadaver study confirmed the IGZO detector performs non-inferiorly to the predicate amorphous-silicon detector for image quality across four anatomical regions.