Cios Spin
Siemens Medical Solutions USA, IncThe Cios Spin is a mobile fluoroscopic C-arm X-ray system designed for use in surgical environments. It enables clinicians to acquire detailed X-ray images during various procedures such as orthopedic, vascular, neurologic, and emergency room interventions. The system provides 3D image acquisition capabilities and integrates with navigation software to help clinicians accurately visualize anatomical structures, thereby enhancing procedural precision and patient care.
Intended Use
Mobile X-ray system designed to provide X-ray imaging of anatomical structures of patients during clinical applications including interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room procedures; applicable to pediatric patients.
Technology
The system consists of a C-arm with an X-ray source and flat panel detector capable of angulation and movement, and an image display station with image processing and documentation capabilities. Software modifications include updated Retina 3D for enlarged 3D volume imaging, NaviLink 3D Lite, Universal Navigation Interface, and updated InstantLink with extended NXS Interface.
Performance
Nonclinical performance tests including electrical safety, EMC, and software verification and validation demonstrate that the device meets FDA performance standards and is safe and effective for its intended use. The device complies with multiple IEC standards and underwent human factors usability validation.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/16/2025
2 months - 2
FDA Approval
7/29/2025
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