Cleared Traditional

Nanox.ARC

K242395 · Nano-X Imaging , Ltd. · Radiology
Dec 2024
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K242395 is an FDA 510(k) clearance for the Nanox.ARC, 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 December 4, 2024, 113 days after receiving the submission on August 13, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1740.

Submission Details

510(k) Number K242395 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 2024
Decision Date December 04, 2024
Days to Decision 113 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