Dec. 05, 2024 — NANO-X IMAGING LTD has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Nanox.ARC, a stationary X-ray system intended to produce tomographic images for general use including human musculoskeletal system, pulmonary, intra-abdominal and paranasal sinus indications, adjunctive to conventional radiography, on adult patients.
The Nanox.ARC utilizes advanced tomosynthesis technology with a cold cathode to create a more comprehensive, sliced three-dimensional view of the body, enhancing visualization with multiple layers of images and reducing the super-imposition of structures often seen in 2D X-rays.
“With this FDA clearance, we can now offer U.S. healthcare providers significantly broader imaging capabilities that are akin to commonly used traditional X-ray devices,” said Erez Meltzer, Nanox Chief Executive Officer and Acting Chairman. “Our mission is to provide healthcare practices with a transformative imaging advantage with the Nanox.ARC – an accessible, cost-effective solution that not only provides advanced diagnostic imaging capabilities but also elevates overall patient care. We look forward to bringing this technology to more healthcare facilities throughout the country.”
The company believes the new FDA-cleared indications will help broaden Nanox. ARC’s commercial expansion in the U.S., where it is currently deployed at multiple healthcare facilities across seven states. Worldwide, there are a few dozen units in various stages of shipments and deployments for both commercial and clinical uses.
“The installation of the Nanox.ARC at our facility marks a significant leap forward in our diagnostic capabilities,” said Sherri Donaldson, COO at Diagnostic Radiology Institute of Kansas City, located in Mission, Kansas. “This technology allows us to provide our patients with advanced imaging services, potentially reducing wait times and improving the overall patient experience. We're excited to be at the forefront of this technological advancement in medical imaging.”
The Nanox.ARC is intended for use in professional healthcare facilities or radiological environments, such as hospitals, clinics, imaging centers and other medical practices, and is operated by trained radiographers, radiologists and physicians. It is designed to allow easy and efficient integration into current clinical workflows. The Nanox.ARC has the potential benefits of reducing patient wait times, enabling faster care and more efficient diagnosis, while also potentially reducing the need to visit a separate imaging facility.
“Digital tomosynthesis provides added value in certain clinical situations. Musculoskeletal, thoracic and abdominal imaging all have use cases that may be best served by digital tomosynthesis compared to CT or radiography,” said Greg Kicska M.D., Ph.D, Assistant Professor at Harborview Medical Center and Nanox Advisory Board Member. “The Nanox system is also unique in that it doesn’t have as large a footprint as traditional X-ray machines, doesn’t require as much power and utilizes a matrix pattern that blurs out structural noise, making images more clean.”
For more information, please visit www.nanox.vision.
September 15, 2026 
