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510(k) Data Aggregation

    K Number
    K220557
    Device Name
    MoistureMeterD Compact, LymphScanner
    Manufacturer
    Delfin Technologies Ltd
    Date Cleared
    2022-05-27

    (88 days)

    Product Code
    OBH
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    Delfin Technologies Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MoistureMeterD Compact and LymphScanner is a device utilizing inter-am ratios of tissue dielectric constant (TDC) that supports local assessment of tissue water differences between affected and contralateral non-affected ann tissues to aid in forming a clinical judgment of unilateral lymphedema in adult women. The device is not intended to make a dagnosis or predict arm lymphedema.
    Device Description
    The MoistureMeterD Compact (MMDC) and the LymphScanner are identical differently labelled bioelectrical analyzers to measure localized tissue fluid content. High-frequency electromagnetic waves produced in the hand-held main unit are guided into integrated open-ended coaxial probe. When the probe is placed onto the skin, skin and upper subcutis is exposed to electromagnetic field. In skin and upper subcutis electromagnetic fields are interacting with tissue water molecules by rotation causing absorption of electromagnetic energy in tissue. The devices measure the amplitude and phase shift of the reflected electromagnetic wave and calculate tissue dielectric constant (TDC). Tissue dielectric constant (TDC) is an index of localized tissue water content. The measured TDC value can be converted into Percentage Water Content (PWC) value.
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    K Number
    K143310
    Device Name
    MoisturemeterD
    Manufacturer
    DELFIN TECHNOLOGIES LTD.
    Date Cleared
    2015-11-19

    (366 days)

    Product Code
    OBH
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    DELFIN TECHNOLOGIES LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Delfin MoistureMeterD is a device utilizing inter-arm ratios of tissue dielectric constant (TDC) that supports local assessment of tissue water differences between affected and contralateral non-affected arm tissues to aid in forming a clinical judgment of unilateral lymphedema in women. The device is not intended to make diagnosis or predict arm lymphedema.
    Device Description
    The Delfin MoistureMeterD is a high-frequency bioelectrical analyzer used to detect tissue fluid. The device accurately measures voltage, current and the phase shift of the reflected current of the attenuated electric field and calculate capacitance and. moreover the tissue dielectric constant (TDC). The tissue dielectric constant (TDC) supports the measurement of local tissue fluid.
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