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510(k) Data Aggregation

    K Number
    K212144
    Device Name
    Remex KA6
    Manufacturer
    Remedi Co. Ltd.
    Date Cleared
    2021-08-03

    (25 days)

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

    Remedi Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KA6 is a portable X-ray system for diagnostic imaging of body extremities.
    Device Description
    The Remex KA6 is a handheld battery-operated x-ray system intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. The subject device is designed as an x-ray source to take diagnostic x-rays as radiographic images. The x-ray tube by Canon (tube voltage 40-70kV with 0.4 mm focal spot) is located inside the handheld device. The device is used with a Flat Panel X-ray Detector(FXRD), not part of the system, which is attached to a computer with imaging software to enable image capture, display, manipulation, storage, and transmission. The device is not designed to be used with a radiographic grid.
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    K Number
    K200284
    Device Name
    R-Sensor, R-Sensor
    Manufacturer
    Remedi Co. Ltd.
    Date Cleared
    2020-02-28

    (23 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Remedi Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    R-Sensor is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures. Radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure. The R-Sensor dental sensor is intended to replace film and to capture an intraoral x-ray image, when exposed to X-rays, for dental diagnostic purposes.
    Device Description
    The subject R-Sensor is an intraoral digital x-ray system comprised of two components: (1) an intraoral detector which connects to a PC via a USB port; and (2) an Image Management Software package. The subject devices comes in two sizes: Size 1 is 600mm² and Size 2 is 884mm². R-Sensor, Size 1 is also known as factory code S11684-12; R-Sensor, Size 2 is also known as factory code S116845-12.
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