Orthoscan TAU Mini C-Arm

The Orthoscan TAU Mini C-Arm is a mobile fluoroscopic X-ray system designed to provide real-time imaging during diagnostic, surgical, and emergency procedures on patients of all ages. It visualizes limbs, extremities, shoulders, knees, and hips in hospitals, surgery centers, emergency rooms, orthopedic clinics, and physician offices using pulsed or continuous fluoroscopy.

The device upgrades the operating system from Ubuntu 16.04 to Ubuntu 20.04 for improved cybersecurity; revises the generator circuit board for better power efficiency; replaces lead-based radiation shielding with an alternate material; updates the wireless footswitch from fixed pairing to code-hopping communication; introduces an alternate detector for model 1000-0017; and adds an optional 32-inch display monitor. All changes maintain identical mechanical function, image clarity, and dose levels as the predicate.

The device was certified compliant with IEC 60601-1 ED 3.2 series including IEC 60601-2-54, IEC 62304:2006 + A1:2015 (medical device software lifecycle), and all applicable sections of 21 CFR Subchapter J performance standards. Software and cybersecurity testing followed FDA guidance documents from 2023.

The proposed device retains the identical control mechanism, operating principle, energy type, and intended use as the predicate Orthoscan TAU Mini C-Arm (K213113). Bench testing with anthropomorphic phantoms and radiologist assessment confirmed image quality at same or similar dose rates is equivalent or slightly improved. Since all modifications are software/component-level (OS, circuit board, shielding material, wireless protocol, optional detector) without changing the fluoroscopic imaging function or clinical application, substantial equivalence is established.