Intended Use

Intended for use by trained or qualified doctors to produce diagnostic X-ray images of extremities in adult and pediatric (over 12 years old) patients using anatomical structures captured by film or image processing systems (workstation) after radiation exposure with cassette IP, CR, or DR (portable flat panel). Only intended for stand-mounted use.

Technology

The system operates as a portable X-ray device with variable tube current (2~5 mA) and voltage (50~90 kV) controlled via up-down push buttons with LED indicators. It uses a rechargeable 22.2V Lithium-Ion Polymer battery and includes an X-ray tube head, high voltage generator, PCB control board, LCD user interface, X-ray beam limiting device, and a remote control switch. It is designed for stand-mounted use and generates X-rays that penetrate patient extremities to create images on film or digital receptors.

Performance

The device underwent successful clinical and non-clinical testing according to multiple IEC and FDA standards for safety, electromagnetic compatibility, radiation protection, and battery safety. Clinical images demonstrated appropriate diagnostic image quality of anatomical structures of upper and lower extremities. It also complies with relevant radiation safety guidelines for hand-held use and cybersecurity requirements.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    12/31/2024

    4 months
  • 2

    FDA Approval

    5/28/2025

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