Nanox.ARC X— 510(k) K250850

Substantially Equivalent

Nano-X Imaging , Ltd.

FDA 510(k) clearance K250850 for Nanox.ARC X, Substantially Equivalent on 2025-04-16. Applicant: Nano-X Imaging , Ltd.. Device class: 2.

Clearance details

Applicant: Nano-X Imaging , Ltd.
Product code: Code IZF
Device class: Class 2
Regulation: 21 CFR 892.1740
Advisory panel: Radiology
Date received: 2025-03-20
Decision date: 2025-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petah Tikva, IL

Download summary PDF View on FDA.gov ↗

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