Nano-X Imaging

FDA Places Nano-X’s 510(k) Submission for Nanox.ARC On Hold

August 23, 2021

Nano-X Imaging has announced that its submission for a 510(k) clearance for its Nanox.ARC multi-source device was placed on hold by the FDA.

A 3-D digital tomosynthesis imaging system that produces scans of a human body part, Nanox.ARC uses multiple X-ray tubes arranged around the patient.

Nano-X said it anticipates filing an additional 510(k) application for the next version of Nanox.ARC during the fourth quarter of 2021, which will benefit from the FDA’s feedback on the first version.

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