Cleared Traditional

K250850 - Nanox.ARC X (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250850 · Nano-X Imaging , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
27d
Days
Class 2
Risk

K250850 is an FDA 510(k) clearance for the Nanox.ARC X. Classified as System, X-ray, Tomographic (product code IZF), Class II - Special Controls.

Submitted by Nano-X Imaging , Ltd. (Petah Tikva, IL). The FDA issued a Cleared decision on April 16, 2025 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1740 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nano-X Imaging , Ltd. devices

Submission Details

510(k) Number K250850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 107d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZF System, X-ray, Tomographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IZF System, X-ray, Tomographic

All 41
Devices cleared under the same product code (IZF) and FDA review panel - the closest regulatory comparables to K250850.
TAP2D
K252649 · Nano-X Imaging , Ltd. · Feb 2026
Adaptix Ortho350
K252133 · Adaptix Limited · Nov 2025
Nanox.ARC
K242395 · Nano-X Imaging , Ltd. · Dec 2024
Nanox.ARC
K222934 · Nano-X Imaging , Ltd. · Apr 2023
Ortho Device, ADAPTIX 3D Orthopedic Imaging System
K221949 · Pausch Medical GmbH · Jan 2023
CLISIS SYSTEMS, Discovery RF180
K213081 · General Medical Merate S.P.A · Oct 2021