Nanox.ARC X

The Nanox.ARC X is a stationary, floor-mounted digital tomosynthesis X-ray system that produces tomographic images of the musculoskeletal system, lungs, abdomen, and sinuses as an adjunct to conventional radiography in adult patients. It is intended for use in professional healthcare facilities by trained radiographers, radiologists, and physicists, with patients positioned prone, supine, or lateral on a motorized table.

Both subject and predicate devices use sequential cold-cathode X-ray sources with five identical tubes, the same detector geometry, and Nanox.CLOUD reconstruction software. The Nanox.ARC X internalizes system electronics (previously external), adjusts the gantry enclosure shape from rounded to square-rounded design, changes X-ray tube housing material from ceramic to glass, and optimizes the patient table footprint—all without affecting core imaging functionality or performance characteristics.

Not stated in this summary.

The subject device maintains identical indications for use, fundamental tomosynthesis operating principles, and core technical parameters (five X-ray sources, detector type, exposure parameters, focal spot size, target angle) as the predicate device K242395. Design modifications—such as internal electronics rearrangement, gantry enclosure shape refinement, tube housing material change, and table footprint optimization—are system-level refinements that do not alter imaging capability. Comprehensive bench testing (electrical qualification, performance, image quality, tube longevity, phantom validation) confirmed the subject device functions as intended with equivalent safety and effectiveness, establishing substantial equivalence despite the cosmetic and structural improvements.