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# Nano-X Imaging Gets Clearance for New X-ray
- URL: https://www.fdaweb.com/nano-x-imaging-gets-clearance-for-new-x-ray/
- Published: 2023-05-03T12:00:00.000Z
- Updated: 2026-09-14T18:29:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154365

FDA has cleared a Nano-X Imaging 510(k) for its Nanox ARC, a stationary X-ray system intended to produce tomographic images of the human musculoskeletal system adjunctive to conventional radiography in adult patients. The clearance also covers the company’s Nanox Cloud, a cloud-based infrastructure.

The company describes Nanox.ARC as a multi-source digital 3D tomosynthesis system that utilizes novel, cold cathode X-ray tubes. The device has the ability to reconstruct a series of 2D projection images into a stack of tomograms (or slices) of the imaged object, forming a 3D visualization, it says. “This visualization reduces the effect of overlying structures and provides in-depth information on structures of interest,” it adds.