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510(k) Data Aggregation

    K Number
    K223556
    Device Name
    DeepCatch
    Manufacturer
    Date Cleared
    2023-06-16

    (200 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICALIP Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    DeepCatch analyzes CT images and auto-segments anatomical structures (skin, bone, muscle, visceral fat, subcutaneous fat, internal organs and central nervous system). Then, its volume and proportions are calculated and provided with the relevant 3D model. By using DeepCatch, it is possible to obtain accurate values for the volume and proportion of each anatomical structures by secondary utilization of CT images obtained for various purposes in the medical field. The type of input data is whole body CT. This device is intended to be used in conjunction with professional clinical judgement. The physician is responsible for inspecting and confirming all results.
    Device Description
    DeepCatch is medial image processing software that provides 3D reconstruction and visualization of ROI, advanced image quality improvement, auto segmentation for specific target, texture analysis, etc. Data that accurately analyzes the amount of skeletal muscle and adipose tissue distributed in the body in 3D can be used as base data in various fields.
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    K Number
    K191026
    Device Name
    MEDIP PRO
    Manufacturer
    Date Cleared
    2019-11-07

    (203 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICALIP Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MEDIP PRO is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also used as pre-operative software for treatment planning. The 3D printed models generated from the output file are meant for non-diagnostic use. MEDIP PRO should be used in conjunction with other diagnostic tools and expert clinical judgement.
    Device Description
    MEDIP PRO is medial image processing software that provides 3D reconstruction and visualization of ROI, advanced image quality improvement, auto segmentation for specific target, texture analysis and etc. through loading DICOM file imaged from CT or MRI by user(doctors). Also, it supports exporting STL data for 3D printing.
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