Europa (Alternative: AiRTouch) portable X-ray system
LIVERMORETECH INCThe Europa (AiRTouch) portable X-ray system is a mobile diagnostic device designed for imaging extremities in both adult and pediatric patients aged 12 and older. It produces high-quality X-ray images using adjustable tube current and voltage and supports image capture through film or digital receptors. This system is portable, battery-operated, and intended for use by trained clinicians, facilitating easier and flexible diagnostic imaging outside traditional radiology suites.
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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