Cleared Traditional

TAP2D

K252649 · Nano-X Imaging , Ltd. · Radiology
Feb 2026
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K252649 is an FDA 510(k) clearance for the TAP2D, 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 February 2, 2026, 165 days after receiving the submission on August 21, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1740.

Submission Details

510(k) Number K252649 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2025
Decision Date February 02, 2026
Days to Decision 165 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