ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno

The ARTIS icono/ARTIS pheno (VE50B) systems are dedicated angiography fluoroscopic X-ray systems for single-plane and biplane diagnostic imaging and interventional procedures. They enable cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography, whole body radiographic/fluoroscopic procedures, image-guided surgery, and optional 3D reconstruction via DynaCT software.

The subject device updated system software from VE40A to VE50B with enhanced Peristepping/Perivision, new postprocessing algorithms (Advanced I-Noise and Extended Overlay Reference), updated ARTIS Touch UI, updated collimators, updated Common Application Hosting, updated user interface, updated ARTIS Profiles, updated imaging system PC hardware, and updated tilt table. For Nexaris Angio-CT configuration, software was updated from VD11D to VE50B with added hardware for CT gantry collision avoidance.

Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-43, IEC 60601-2-54, ISO 10993-1, ISO 14971, ISO 15223-1, ISO 20417, IEC 62304 (software lifecycle), and IEC 62366-1 (usability engineering), among others. Software testing per FDA's 'Guidance for the Content of Premarket Submissions for Device Software Functions' at Basic level of concern.

The ARTIS icono/ARTIS pheno (VE50B) is substantially equivalent to the legally marketed predicate ARTIS icono/ARTIS pheno (VE40A) (K241572) because it maintains identical indications for use, identical device class and regulation, comparable technological characteristics with only software and hardware enhancements, and non-clinical performance data demonstrating the same safety and effectiveness profile without raising new safety or effectiveness issues.