EXTRON 3; EXTRON 5; EXTRON 7

The EXTRON Series are mobile fluoroscopic X-ray systems designed to provide real-time X-ray images of patient anatomy during surgery and treatment procedures. They are used in emergency injury treatment, orthopedic surgery, neurosurgery, bone surgery, and other interventional applications, with the ability to save and transmit images to hospital PACS systems. The devices are not intended for mammography applications.

The EXTRON Series comprise a C-arm main body with X-ray tube, flat panel detector, collimator, generator, and monitor cart with display and printer. EXTRON 3 uses a stationary anode while EXTRON 5 and 7 use rotating anodes. Operating parameters include kV range of 40-120kV and variable mA ranges (up to 30-150mA depending on model and mode). Detector pixels range from 1500×1500 to 2048×2048, with DQE of 55% @1lp/mm and MTF of 55% @1lp/mm. The device offers 165° orbital movement with immersion depths of 73-74cm.

The device complies with ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-43, IEC 60601-2-54, IEC 62304, IEC 62366-1, IEC 81001-5-1, and ANSI UL 2900-1. FDA guidance documents cited include 510(k) premarket notification, device software functions, X-ray imaging conformance, electromagnetic compatibility, human factors, and cybersecurity.

Substantial equivalence is established through technological and performance parity with predicate devices Veradius Unity (K142708), OEC 9900 ELITE (K122234), and EXTRON 5/7 (K230871). Although minor differences exist in detector pixels, DQE, and MTF specifications, phantom image comparisons by qualified clinicians confirmed equivalent or superior image quality. The subject device operates within the same kV/mA ranges and maintains comparable immersion depth and orbital movement to predicates. All devices share the same fundamental X-ray imaging principles, classification, and intended uses across equivalent clinical applications, with compliance to identical international safety standards demonstrating no novel safety or effectiveness concerns.