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Intended Use

EXTRON Series are a mobile fluoroscopic X-ray system with high output capacity, high thermal capacity and high resolution image processing system, which provides X-ray images of the patient's anatomy during surgery or treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, neurosurgery surgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis. Examples of a clinical application may include: Neurosurgery, Orthopedics, Anesthesiology, Urology, Gynecology, Internal Medicine (※ This device is not intended for mammography applications.)

Technology

The EXTRON Series are composed of a C-arm main body with an X-ray tube, flat panel detector, collimator, generator, control panel components, and a monitor cart with display and printer. The device generates X-ray beams which penetrate the body and are converted via sensors into digital signals. These images are processed and displayed with high resolution on monitors for real-time guidance during surgery. Images can be saved or transmitted to external systems such as PACS.

Performance

Non-clinical testing demonstrated image quality, safety, and performance equivalence to predicate devices including Veradius Unity and OEC 9900 ELITE. Compliance with multiple international standards (IEC 60601 series, ISO 14971, FDA guidance) was confirmed. Phantom images were clinically reviewed for equivalence; no clinical studies were conducted. Overall, the EXTRON Series is substantially equivalent in safety and effectiveness.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    1/2/2025

    5 months
  • 2

    FDA Approval

    6/10/2025

Other devices from DRTECH Corporation

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