OEC One ASD

The OEC One ASD is a mobile C-arm X-ray system designed to provide fluoroscopic and digital spot images during diagnostic, interventional, and surgical procedures in adult and pediatric patients. Clinical applications include orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures.

The primary change is replacement of the image intensifier with a 21cm amorphous silicon (a-Si) flat panel detector, which improves Detective Quantum Efficiency (70% vs 65%) and maintains comparable Modulation Transfer Function (46% vs 45%). The image shape changed from circular to squircle, image matrix size increased to 1520×1520, and anti-scatter grid specifications were updated (74 L/cm, 14:1 ratio). The X-ray generator, monoblock, and control modes remain identical. Hardware upgrades include higher-resolution monitor (3840×2160), increased image storage (150,000 images), wireless printing, and updated tablet OS (Android 11.0).

IEC 60601-1 series, IEC 60601-2-28, IEC 60601-2-54, IEC 60601-2-43, IEC 62304, IEC 62366-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, ANSI AAMI ES60601-1, NEMA XR-27, and applicable parts of 21 CFR Subchapter J including 1020.30, 1020.32, and 1040.10.

The OEC One ASD uses the same fundamental scientific technology and design control processes as the predicate OEC One (K182626), with identical indications for use and X-ray generation/control mechanisms. Although the flat panel detector improves performance metrics compared to the image intensifier, no new hazards or safety concerns are introduced; performance testing demonstrates the device remains effective. The changes to secondary components (monitor, tablet, printer, collimator shape) are driven by IT technology advancement and do not alter the device's operating principle or safety profile, thus supporting substantial equivalence.