NANO-X IMAGING LTD announced today 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 clearance was granted in less than 30 days from the submission date.
The Nanox.ARC X is cleared for general use, including the human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indications, adjunctive to conventional radiography on adult patients. This new system integrates the proprietary digital Nanox.SOURCE and advanced tomosynthesis technology with a cold cathode, providing a comprehensive 3D view of the body.
A key feature of the Nanox.ARC X is its fully integrated, single-unit design with a streamlined physical footprint and 'plug and play' one-day installation capability. This design makes advanced tomosynthesis technology more accessible to diverse healthcare settings with space constraints, operating on standard power and featuring a cable-free design for enhanced safety and maintenance. Nanox plans to offer the Nanox.ARC X system later this year, alongside the current Nanox.ARC.
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