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510(k) Data Aggregation

    K Number
    K260093

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-31

    (77 days)

    Product Code
    Regulation Number
    892.1750
    Age Range
    0 - 150
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K243088, K241114, K231757, K223820, K222069

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

    PHT-70CHS is intended to produce panoramic, cephalometric, or 3D digital x-ray images. It provides diagnostic details of the dento-maxillofacial, sinus, and TMJ for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by healthcare professionals.

    Device Description

    The PHT-70CHS is a 4-in-1 digital X-ray system designed for both 2D and 3D dental radiographic imaging. The system integrates panoramic imaging, optional cephalometric imaging, dental computed tomography, and model imaging functions into a single unit. It is intended for dental diagnostic purposes and is capable of acquiring and processing multi-field-of-view digital radiographic images.

    The PHT-70CHS is a complete digital radiographic imaging system that includes an X-ray generator, dedicated image receptors, and compatible image viewing software. The system supports acquisition of both 2D diagnostic images, including panoramic and cephalometric images, and 3D diagnostic images using cone beam computed tomography.

    The materials, safety characteristics, X-ray source, indications for use, and image reconstruction including metal artifact reduction algorithms of the subject device are the same as those of the predicate devices PHT-75CHS (K231796) and PHT-90CHO (K243081).

    Green X 12 VE and Green X VE are differentiated by the configuration of the CT and panoramic image receptors, which is reflected in their respective trade naming. Green X 12 VE is equipped with the Xmaru1404CF-PLUS Eth detector, while Green X VE is equipped with the Jupi0606X1 detector. Both configurations utilize the Xmaru2602CF Eth detector for cephalometric imaging.

    AI/ML Overview

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