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510(k) Data Aggregation

    K Number
    K213405
    Device Name
    MINE ALNU (Model: Mine 2.1)
    Manufacturer
    Date Cleared
    2022-07-10

    (264 days)

    Product Code
    Regulation Number
    892.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    HDT Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Mine 2.1 is a portable medical diagnostic-purpose X-ray generator that can be hand-held. The device uses an adjustable tube voltage and a fixed tube current for producing diagnostic x-ray images of extremities for both adults and pediatrics. It is intended to be used by a qualified and trained clinician on all patients. It is not intended to replace a radiographic system with variable tube current and voltage (kVp) which may be required for full optimization of image quality and radiation exposure for different exam types.
    Device Description
    Mine 2.1, a portable X-ray generator, is radiation medical equipment that can only be used by professional radiologists. It controls and marks X-ray dose within the range of X-ray exposure limited by hardware. Also, it uses the algorithm of X-ray output for processing and control. This portable X-ray generator requires equipment for X-ray imaging in order to generate X-ray images. Small in size, this product is convenient to carry with, and suitable for being moved around. The main body can be compatibly used with a stand. When attached to a stand, it is easy to adjust positioning for medical imaging. MINE ALNU is programmed to be inoperable when the SSD is less than 40cm to the irradiation target. The VL53L1X, a laser-ranging sensor, the fastest miniature Time-of-Flight (ToF) sensor on the market with accurate ranging up to 4 m and fast ranging frequency up to 50Hz. VL53L1X contains a laser emitter and corresponding drive circuitry. The laser output is designed to remain within Class 1 laser safety limits under all reasonably foreseeable conditions including single faults in compliance with IEC 60825-1: 2014. The x-ray detectors, a necessary part of a complete imaging system, are not part of the current submission. The device is not intended to be used with a mechanical grid.
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