Agfa HealthCare has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Xero mobile viewer for diagnostic viewing.
The device's "full fidelity view" allows users to retrieve original stored computed radiography, digital radiography, CT, MR, and ultrasound images for diagnostic purposes. It also features cine display, universal video viewing, optional tools for 3D multiplanar reformats (MPRs) and maximum intensity projections (MIPs), and the ability to view electrocardiograms in various layouts, according to the firm.
More than 500 Xero viewers have been installed around the world, Agfa said.
