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K Number
K252649

Validate with FDA (Live)

Device Name
TAP2D
Manufacturer
Nano-X Imaging , Ltd.
Date Cleared
2026-02-02

(165 days)

Product Code
IZF,LLZ,MQB
Regulation Number
892.1740
Type
Traditional
Panel
Radiology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 892.1740 Tomographic x-ray system.

(a)
Identification. A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.