NANO-X IMAGING Gets FDA Clearance For Nanox.ARC X, New Multi-source Digital Tomosynthesis System

• First FDA clearance for Nanox.ARC X to produce tomographic images for general use, including musculoskeletal, pulmonary, intra-abdominal and paranasal indications
• Enhanced imaging system features sleek design with smaller footprint; simplified ‘plug and play' installation process
• System design enables software upgrades and new capabilities to be added remotely following future regulatory clearances
  
   

PETACH TIKVA, Israel, April 17, 2025 (GLOBE NEWSWIRE) -- NANO-X IMAGING LTD ((", Nanox", or the ", Company", , NASDAQ:NNOX), an innovative medical imaging technology company, today announced that it 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