Cleared Traditional

Nanox.ARC X

K250850 · Nano-X Imaging , Ltd. · Radiology
Apr 2025
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K250850 is an FDA 510(k) clearance for the Nanox.ARC X, a System, X-ray, Tomographic (Class II — Special Controls, product code IZF), submitted by Nano-X Imaging , Ltd. (Petah Tikva, IL). The FDA issued a Cleared decision on April 16, 2025, 27 days after receiving the submission on March 20, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1740.

Submission Details

510(k) Number K250850 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 2025
Decision Date April 16, 2025
Days to Decision 27 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IZF — System, X-ray, Tomographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1740