EXTRON 3;EXTRON 6
DRTECH CorporationEXTRON 3 and EXTRON 6 are mobile fluoroscopy X-ray machines that provide real-time imaging during surgeries and treatments. They help medical staff visualize a patient's anatomy in various procedures, making diagnosis and guidance during treatment easier and more effective.
Intended Use
EXTRON Series are mobile fluoroscopic X-ray systems used to provide real-time X-ray images of patient anatomy during surgery or treatment, supporting emergency injury treatment, orthopedic, neurosurgery, bone surgery, and more. Enables saving, searching, and transmitting images to the PACS system for diagnosis support.
Technology
The systems consist of a mobile C-arm with X-ray tube, flat panel detector, generator, collimator, and digital imaging components, plus a monitor cart for display and control. They generate real-time fluoroscopic images via digital conversion and image processing technologies, supporting storage and PACS export.
Performance
Bench testing demonstrated compliance with a broad range of international and FDA-recognized consensus standards (e.g., IEC 60601-series, IEC 62366, IEC 62304, UL 2900-1), and usability and cybersecurity standards. Qualified clinicians also reviewed clinical images, confirming image quality is equivalent to predicate devices.
Predicate Devices
No predicate devices specified
Ready to Sharpen Your Edge?
Subscribe to join 11k+ peers who rely on RadAISlice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.