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510(k) Data Aggregation

    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
    All
    Reference & Predicate Devices
    K100372,K160852,K250850
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K100372, K160852

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    TAP2D is a cloud-based software-module accessory intended exclusively for use with the Nanox.ARC X and Nanox.ARC systems, consistent with their cleared indications for use.

    TAP2D is intended to provide a supplemental processed and enhanced 2D view image in DICOM format of a single 2D projection extracted from the acquired DTS study.

    TAP2D is specifically indicated for assisting radiologists when evaluating diagnostic tomosynthesis studies and reaching their own diagnosis.

    Device Description

    TAP2D is a cloud-based software-module accessory for Nanox.ARC X and Nanox.ARC systems. It provides a supplemental enhanced 2D view image in DICOM format, of a 2D projection extracted from the DTS study acquisition by these systems.

    TAP2D image is intended for assisting radiologists when evaluating tomosynthesis studies, by providing an enhanced, high-contrast single-2D-view image of the DTS scan.

    TAP2D image is clearly tagged as a supplemental view in DICOM and transmitted to PACS alongside the diagnostic DTS series.

    AI/ML Overview

    N/A

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