Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K253244

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-02-23

    (147 days)

    Product Code
    Regulation Number
    892.1720
    Age Range
    18 - 999
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AirRay-mini is a handheld, portable X-ray generator.

    This device is intended for use by qualified and trained healthcare professionals on adult patients to produce diagnostic X-ray images of the extremities.

    This device is not intended for mammography.

    Device Description

    The AirRay-mini is a portable, battery-powered X-ray generator intended to provide controlled X-ray radiation for use with separately cleared solid-state detectors or digital radiography systems. The device consists of an X-ray control unit, a high-voltage generator, an X-ray tube assembly, a hand switch, and associated electronics.

    DC power from the internal battery is supplied to the inverter, which generates a high-voltage output applied across the X-ray tube. Electrons emitted from the cathode are accelerated toward the anode target, where their deceleration produces X-ray radiation. The device delivers X-rays according to user-selected parameters such as tube voltage (kV), tube current (mA), and exposure time (mAs).

    The AirRay-mini does not include an image receptor and does not acquire or process diagnostic images. Diagnostic image formation and quality depend entirely on the separately paired imaging system.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1