Nano-X Imaging (NNOX) said Thursday it received 510(k) clearance from the U.S. Food and Drug Administration for its Nanox.ARC stationary X-ray system.
The Nanox.ARC system is designed to produce tomographic images for general use, complementing conventional radiography, on adults. The system uses a proprietary digital X-ray source and advanced tomosynthesis technology with a cold cathode to generate 3D images.
The company said the clearance will help broaden Nanox.ARC's commercial expansion in the U.S., which is currently deployed in healthcare facilities across seven U.S. states, and with "a few dozen units in various stages of shipments and deployments" for commercial and clinical uses worldwide.
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