The system is cleared to produce tomographic images for general use, including musculoskeletal, pulmonary, intra-abdominal, and paranasal indications.
Nanox Imaging, a medical imaging technology company, announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Nanox.ARC X, its new multi-source digital tomosynthesis system.
The FDA 510(k) clearance covers the production of tomographic images for general use, including the human musculoskeletal system and pulmonary, intra-abdominal, and paranasal sinus indications, adjunctive to conventional radiography on adult patients.
The Nanox.ARC X maintains the Nanox.ARC’s digital Nanox.SOURCE and tomosynthesis technology with a cold cathode, which is designed to create a more comprehensive, sliced three-dimensional view of the body, enhance visualization with multiple layers of images, and reduce the superimposition of structures often seen in 2D X-rays.
The Nanox.ARC X is a fully integrated, single-unit system with a streamlined design that reduces the physical footprint. The system features “plug and play” installation capability.
“The FDA clearance of the Nanox.ARC X marks an important evolution in our imaging technology,” says Erez Meltzer, chief executive officer and acting chairman of Nanox, in a release. “By integrating our proprietary digital technology in this new imaging system, we’re making it easier for healthcare providers to adopt digital 3D imaging. This milestone advances our mission to expand access to essential medical imaging technology to more patients, regardless of their location. We look forward to introducing further capabilities to the Nanox.ARC X in the future and making them available through remote and immediate upgrades.”
The Nanox.ARC X is designed to be installed in any standard X-ray shielded room with minimal infrastructure requirements. The system operates on standard power (110v/230v 16A) and features a cable-free design for enhanced user and patient safety, ease of cleaning, and maintenance.
Nanox will offer the Nanox.ARC X system later this year alongside the current Nanox.ARC, expanding the company’s product portfolio to meet customer needs and use cases.
Photo caption: Nanox.ARC X
Photo credit: Nanox
