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510(k) Data Aggregation

    K Number
    K250750
    Device Name
    INNOVISION-P5
    Manufacturer
    DK Medical Systems Co., Ltd
    Date Cleared
    2025-07-18

    (128 days)

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

    DK Medical Systems Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K242119
    Device Name
    INNOVISION-EXII
    Manufacturer
    DK Medical System
    Date Cleared
    2025-01-03

    (168 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    DK Medical System

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INNOVISION-EXII is a stationery X-ray system intended for obtaining radiographic images of various anatomical parts of the human body, both pediatrics and adults, in a clinical environment. INNOVISION-EXII is not intended for mammography, angiography, interventional, or fluoroscopy use.
    Device Description
    INNOVISION-EXII can receive X-ray signals from X-ray irradiation and digitize them into X-ray images by converting digital images to DICOM image format using Elui imaging software. INNOVISION-EXII is a general radiography X-ray system and not for mammography nor fluoroscopy. In addition, the system must be operated by a user who is trained and licensed to handle a general radiography X-ray system to meet the regulatory requirements of a Radiologic Technologist. Target areas for examinations include the head, spine, chest, and abdomen for diagnostic screening of orthopedic, respiratory, or vertebral discs. The system can capture a patient's postures, such as sitting, standing, or lying. This system can be used for patients of all ages, but it should be used with care for pregnant women and infants. The INNOVISION-EXII system has no part directly touching the patient's body.
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