Siemens Healthineers Receives 510(k) Clearance for Angiography Device

Siemens Healthineers has received 510(k) clearance from the FDA for the latest version of its ARTIS angiography system, the ARTIS icono ceiling.

The ceiling-mounted imaging system is designed for use in interventional radiology and cardiology procedures as well as surgical procedures.

The system features a high degree of mechanical flexibility for accurate positioning. The greater rotational capabilities and simplified cabling enables the system to acquire computed tomography images in 2.5 seconds at the head and 4 seconds at the right and left side of a patient's body.

The system’s open-architecture also allows for adding other vendor-neutral products, the company said.