Nano-X Imaging (Nanox) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TAP2D cloud-enabled image enhancement for the Nanox.ARC and Nanox.ARC X digital tomosynthesis systems.
TAP2D provides radiologists with an additional 2D view generated from the digital tomosynthesis scan and automatically delivered within the existing clinical environment. The feature is designed to support evaluation while maintaining a smooth workflow for users Nanox said.
Nanox.ARC and Nanox.ARC X are FDA-cleared, multisource digital tomosynthesis systems that use 3D imaging technology to provide enhanced diagnostic capabilities at a lower cost and radiation dose than traditional systems.
Nanox said that it plans to make TAP2D available to existing installations as part of an ongoing rollout of imaging improvements.
TAP2D and other software upgrades and new capabilities can be added remotely to the Nanox.ARC systems following this and future regulatory clearances, the firm added.
