TAP2D

TAP2D is a cloud-based software accessory for Nanox.ARC X and Nanox.ARC tomosynthesis systems that provides a supplemental enhanced 2D view image in DICOM format extracted from the acquired DTS study. It is intended to assist radiologists when evaluating diagnostic tomosynthesis studies by presenting an enhanced, high-contrast single 2D projection image alongside the diagnostic DTS series without altering the original data.

TAP2D is a software-only post-processing module (SaMD) deployed in Nanox.CLOUD infrastructure with no image acquisition capability, user interface, or manual activation required. It differs from the predicate Nanox.ARC X hardware-based acquisition system by operating automatically and producing only a supplemental 2D output rather than controlling hardware, but both use the same cloud processing location and DICOM format.

Not stated in this summary.

TAP2D is substantially equivalent to Nanox.ARC X because it functions as an automatic post-processing accessory that produces a supplemental output from existing predicate device data without altering the predicate's functionality, raw data, or clinical performance. Both devices operate within the same clinical scope and workflow; TAP2D introduces no new clinical claims, safety concerns, or effectiveness questions, as confirmed by software verification, system performance testing, image quality assessment, and independent radiologist clinical validation.