Nano-X Imaging , Ltd. FDA Approvals

0 new drug approvals and 5 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
TAP2D510(k)Feb 2, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 2, 2026
Nanox.ARC X510(k)Apr 16, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 16, 2025
Nanox.ARC510(k)Dec 4, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 4, 2024
Nanox.ARC510(k)Apr 28, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 28, 2023
Nanox Cart X-ray System510(k)Apr 1, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 1, 2021