SKAN C PULSAR

The SKAN C Pulsar is a mobile surgical C-arm X-ray system that provides real-time fluoroscopic images during diagnostic, surgical, and interventional procedures. It is intended for use by trained healthcare professionals in applications including orthopedic, GI, neurology, urology, vascular, critical care, and emergency room procedures, but is not recommended for cardiac applications.

The device uses a flat panel detector with multiple technology options (CMOS, amorphous silicon, and IGZO), a rotating anode X-ray tube, and operates at 40–120 kV and up to 60 mA in fluoroscopic mode. It features orbital and rotational C-arm movements, immersion depth of 74 cm, and free space of 82.5 cm, with maximum power output of 6 kW, comparable to the primary predicate device (Extron 5/7).

Device testing complied with IEC 60601 series standards (60601-1, -1-2, -1-3, -1-6, 2-43, 2-54, 2-28), IEC 62304 (software lifecycle), IEC 62366-1 (usability), ISO 14971 (risk management), and NEMA XR 27. FDA guidance documents for 510(k) submissions, solid-state X-ray imaging devices, software functions, cybersecurity, and electromagnetic compatibility were applied.

The SKAN C Pulsar is substantially equivalent to the primary predicate device (Extron 5/7, K230871) based on identical intended use, same regulatory class and product codes, comparable system design and operating principles, and similar technological characteristics including power output and operating parameters. Minor differences in detector specifications (pixel size, DQE values) do not impact safety or effectiveness, as demonstrated by comparison with reference devices using similar detector technologies.