Nanox Imaging Ltd has received United States Food and Drug Administration (FDA) 510(k) clearance for TAP2D, a new cloud-enabled image enhancement capability for its Nanox.ARC and Nanox.ARC X digital tomosynthesis systems.
The clearance, announced on February 3, 2026, marks a key regulatory milestone in the company’s strategy to advance its imaging platforms toward standalone primary diagnostic use in the US market.
The newly cleared TAP2D capability generates a high-quality two-dimensional image directly from a tomosynthesis scan, allowing radiologists to access both 3D and 2D views from a single acquisition. This approach eliminates the need for an additional scan and does not expose patients to any extra radiation. The feature is designed to integrate seamlessly into existing clinical workflows, with the 2D image automatically delivered within the current diagnostic environment without adding operational complexity.
The clearance supports the next phase of Nanox’s regulatory development, with the long-term objective of removing the adjunctive use designation for its tomosynthesis systems in the United States. Achieving this would allow the Nanox.ARC platform to function as a primary diagnostic imaging solution, similar to its current status in Europe under CE Mark certification.
Nanox.ARC and Nanox.ARC X are FDA-cleared, multi-source digital tomosynthesis systems that use advanced three-dimensional imaging technology to deliver enhanced diagnostic performance at a lower cost and radiation dose compared to traditional imaging systems. A key differentiator of the platform is its software-driven architecture, which allows new capabilities and upgrades, including TAP2D, to be deployed remotely following regulatory approvals.
Nanox plans to roll out the TAP2D enhancement to existing installations as part of its broader strategy to continuously expand imaging functionality and clinical value through software updates. The company said the clearance reinforces its commitment to improving access to advanced medical imaging and supporting radiologists with tools that enhance diagnostic efficiency and patient care.
