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

Other devices from Siemens Medical Solutions USA, Inc

Ready to Sharpen Your Edge?

Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.

We respect your privacy. Unsubscribe at any time.