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510(k) Data Aggregation

    K Number
    K251255
    Device Name
    LymphaTech Mobile 3D Measuring Tool
    Manufacturer
    Date Cleared
    2025-07-22

    (90 days)

    Product Code
    Regulation Number
    N/A
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    Product Code :

    SFG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LymphaTech Mobile 3D Measuring Tool is a software application that uses input from the Structure Sensor, an off-the-shelf long-wave infrared camera, to measure the diameter, surface area, volume, and perimeter/circumference of a part of the body. The 3D Measuring Tool is non-contact with respect to the patient and provides an adjunctive tool to help a qualified health care professional measure and record body part data. The device uses input from the Structure Sensor camera to accurately capture and construct a 3D model of a patient's anatomy. It is intended for trained and qualified healthcare professionals, who are trained in its use. The 3D Measuring Tool is to be used on a patient population that includes non-pregnant female or male adults. The 3D Measuring Tool is intended to be used in any environment where health care is provided by a qualified health care professional. The 3D Measuring Tool does not provide a diagnosis or therapy.
    Device Description
    The LymphaTech Mobile 3D Measuring Tool is a standalone software mobile application that uses a high-accuracy off-the-shelf long-wave infrared camera for measuring the diameter, surface area, volume, and circumference of a part of the body. The software allows clinicians to measure body region volume, circumference, surface area, and length with high precision. Specifically, this device uses an off-the-shelf depth sensing scanner, which is a type of long-wave infrared camera, together with an off-the-shelf iPad to acquire complete 3D renderings of the body regions.
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