Nanox has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for Nanox.ARC X, its new multi-source digital tomosynthesis system.

The FDA nod covers 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. According to Nanox, the clearance was received in under 30 days from the date of submission to the FDA.

Nanox.ARC X features a cold cathode, which the company said lets it create more comprehensive, sliced 3D view of the body. It also provides more visualization with multiple image layers and reduces super-imposition of structures often seen in 2D X-rays.

The fully integrated, single-unit system has a design that reduces its physical footprint. It touts “plug and play” one-day installation capability so advanced tomosynthesis can become more accessible to healthcare settings with space constraints.

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 cables-free design for enhanced user and patient safety, ease of cleaning, and maintenance.

The company will begin selling it later this year.

“The FDA clearance of the Nanox.ARC X marks an important evolution in our imaging technology,” said Erez Meltzer, CEO and acting chairman of Nanox. “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.”

Last month, the company won CE mark clearance for Nanox.ARC, a stationary X-ray system intended to generate tomographic images of human anatomy from a single tomographic sweep performed in recumbent positions of adult patients.