ARTIS genio floor; ARTIS icono.explore floor

The ARTIS genio floor and ARTIS icono.explore floor are dedicated angiography systems designed for single-plane and biplane diagnostic imaging and interventional procedures. They enable visualization of blood vessels and allow physicians to navigate catheters and devices safely during cardiac, neuro, and general angiography procedures, as well as surgical guidance and image-guided interventions.

The subject devices feature updated system software (VE50B versus VE40A), including enhanced peristepping/perivision for leg visualization, new postprocessing algorithms (Advanced I-Noise and Extended Overlay Reference), updated touch UI, revised collimators, updated hardware, an optional new Trixell 2121S flat detector, and modifications to tables and floor stands. All components maintain the same functional architecture as the predicate with improved imaging and user interface capabilities.

Testing verified compliance with IEC 60601 series standards for medical electrical equipment safety, IEC 62304 for software lifecycle processes, ISO 13485 for quality management, ISO 14971 for risk management, IEC 60825-1 for laser safety, and NEMA DICOM standards for medical imaging communications. Bench testing, software validation, and clinical image evaluation were all conducted with passing results.

The subject devices are substantially equivalent because they perform the same intended functions as the predicate ARTIS icono (VE40A) for angiographic imaging and interventional procedures. The modifications represent evolutionary improvements in software, hardware, and user interface that do not change the fundamental device design or safety profile; non-clinical performance testing demonstrates the devices are as safe and effective as the predicate for the same indicated uses.