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510(k) Data Aggregation

    K Number
    K053162
    Device Name
    DEXTROSCOPE & DEXTROBEAM
    Manufacturer
    VOLUME INTERACTIONS PTE LTD
    Date Cleared
    2005-12-09

    (25 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Volume Interactions Pte Ltd's Image Processing System is a medical device for the display and visualization of 3D medical image data derived from tomographic radiology images. It is intended to be used by qualified and trained medical professionals, after proper installation.

    Volume Interactions Pte Ltd's Image Processing System is not intended to be used in direct contact with the patient nor is it intended to be connected to equipment that is used in direct contact with the patient.

    Device Description

    Image Processing System

    AI/ML Overview

    The provided text is a determination letter from the FDA regarding a 510(k) premarket notification for an "Image Processing System." It does not contain information about acceptance criteria, device performance, validation studies, sample sizes, or expert qualifications. Therefore, I cannot provide the requested information based on the given text.

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