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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.

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    K Number
    K250976

    Validate with FDA (Live)

    Device Name
    Airbile-100
    Manufacturer
    Date Cleared
    2025-12-19

    (263 days)

    Product Code
    Regulation Number
    892.1720
    Age Range
    0 - 150
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Airbile-100 Mobile X-ray Unit is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.

    Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

    Device Description

    The 'Airbile-100' is a battery-powered mobile X-ray imaging device mainly used for hospital rounds and consists of an X-ray control unit, a high-voltage generator, an X-ray tube unit, a hand switch, etc. Inverter X-ray high-voltage device, electrons are generated from the tungsten filament on the cathode side of the X-ray tube. DC power is supplied to the inverter by a battery, and a high-frequency, stable, high-voltage DC output voltage with an amplified high frequency is applied between the cathode and anode, so that the generated electrons move at high speed due to the voltage difference and are slowed down by striking the target material on the anode, and the energy is converted, and the X-rays generated by the energy conversion are passed to the human body parts for the necessary diagnosis of the patient. It is a device that can generate X-rays according to the set values such as supply voltage, supply current, and irradiation time and take pictures for the necessary diagnosis of the patient.

    Additionally, it should be noted that the Airbile-100 does not include the X-ray detector. For image acquisition, an external X-ray detector must be used in combination with this device.

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