Core Insights - Nanox Imaging Ltd has received FDA 510(k) clearance for its new multi-source digital tomosynthesis system, Nanox.ARC X, in under 30 days from submission, allowing for tomographic imaging for various medical indications [1][7] - The Nanox.ARC X system features advanced technology that enhances imaging capabilities, reduces physical footprint, and allows for easy installation, making it suitable for diverse healthcare environments [2][3] Product Features - The Nanox.ARC X utilizes proprietary digital technology and cold cathode tomosynthesis to provide a comprehensive 3D view of the body, improving visualization and reducing structural overlap seen in traditional 2D X-rays [2][7] - The system is designed for minimal infrastructure requirements, operates on standard power, and has a cables-free design for improved safety and maintenance [3] Strategic Vision - The company aims to expand access to essential medical imaging technology, enhancing early detection and treatment capabilities through a seamless end-to-end solution that integrates AI and cloud-based data management [5][6] - Nanox plans to introduce the Nanox.ARC X later this year, expanding its product portfolio to cater to various customer needs and use cases [4]
Nanox Receives FDA Clearance for General Use of New Imaging System, Nanox.ARC X