Cios Spin

The Cios Spin is a mobile C-arm X-ray fluoroscopic system designed to provide real-time X-ray imaging during clinical procedures including interventional fluoroscopy, orthopedic, vascular, cardiac, and emergency room applications. It can image pediatric and adult patients and consists of a C-arm acquisition unit with X-ray source and flat panel detector, plus a separate image processing and display station connected by cable.

The subject device (VA31A) updates the predicate device (VA30) with enhanced software including: optional enlarged 3D volume reconstruction (25cm × 25cm × 16cm versus prior 16cm × 16cm × 16cm), introduction of NaviLink 3D Lite, Universal Navigation Interface (UNI), and extended NXS interface for InstantLink. Hardware updates include a new collimator, upgraded FLC imaging system PC, AppHost PC with high-performance graphics card, and replacement of the UPS unit due to obsolescence.

Compliance with 21 CFR 1020.30 (Diagnostic X-Ray Systems) and 1020.32 (Fluoroscopic Equipment); IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-28, 60601-2-43, 60601-2-54, 60825-1, 62304, 62366-1; ISO 14971; AAMI ANSI 60601-1-2:2014; and NEMA PS 3.1:2023e for electrical safety, performance, and electromagnetic compatibility.

The device maintains identical indications for use and classification as the predicate (Class II image-intensified fluoroscopic X-ray system). Software modifications were previously cleared features in the CIARTIC Move reference device (enlarged 3D volume, UNI), demonstrating precedent safety and effectiveness. All modifications underwent verification and validation testing including unit, subsystem, and system integration testing with acceptance criteria met. The device complies with the same applicable standards and regulatory requirements as the predicate, with no new safety or effectiveness risks identified.