April 17, 2025 — Nano-X Imaging LTD has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Nanox.ARC X, its new multi-source digital tomosynthesis system.
The FDA 510(k) clearance was received in less than 30 days from the date of submission and covers the production of tomographic images for general use, including the human musculoskeletal system and pulmonary, intra-abdominal and paranasal sinus indications, adjunctive to conventional radiography on adult patients.
The Nanox.ARC X maintains the Nanox.ARC’s proprietary digital Nanox.SOURCE and advanced tomosynthesis technology with a cold cathode, which enables it to create a more comprehensive, sliced three-dimensional view of the body, enhance visualization with multiple layers of images, and reduce the super-imposition of structures often seen in 2D X-rays. The Nanox.ARC X introduces a fully integrated, single-unit system with a streamlined design that significantly reduces the physical footprint. The system features 'plug and play' one-day installation capability, making advanced tomosynthesis technology more accessible to diverse healthcare settings with space constraints.
“The FDA clearance of the Nanox.ARC X marks an important evolution in our imaging technology,” said Erez Meltzer, Chief Executive Officer and Acting Chairman of Nanox. “By integrating our proprietary digital technology in this new imaging system, we’re making it easier for healthcare providers to adopt digital 3D imaging. This milestone advances our mission to expand access to essential medical imaging technology to more patients, regardless of their location. We look forward to introducing further capabilities to the Nanox.ARC X in the future and making them available through remote and immediate upgrades.”
The Nanox.ARC X is designed to be installed in any standard X-ray shielded room with minimal infrastructure requirements. The system operates on standard power (110v/230v 16A) and features a cables-free design for enhanced user and patient safety, ease of cleaning, and maintenance.
Nanox will offer the Nanox.ARC X system, later this year, alongside the current Nanox.ARC, expanding the Company’s product portfolio to meet diverse customer needs and use cases.
For more information about Nanox's complete suite of medical imaging products, please visit www.nanox.vision.
June 02, 2025 
