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510(k) Data Aggregation

    K Number
    K032924
    Device Name
    RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3
    Manufacturer
    VOLUME INTERACTIONS PTE LTD
    Date Cleared
    2003-10-10

    (18 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 CT and MRI scans. It is intended to be used by qualified and trained medial 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 (RadioDexter™ 1.0, Dextroscope™ MK10, and Dextrobeam™ MK3)

    AI/ML Overview

    This FDA 510(k) clearance letter for the "Image Processing System (RadioDexter™ 1.0, Dextroscope™ MK10, and Dextrobeam™ MK3)" does not contain information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria.

    The letter primarily:

    • Confirms the device's substantial equivalence to a legally marketed predicate device.
    • States the device's classification (Class II, Product Code 90 LLZ).
    • Outlines general regulatory requirements for marketing the device.
    • Includes an "Indications for Use Statement" that describes the device's purpose: "a medical device for the display and visualization of 3D medical image data derived from CT and MRI scans" and that it's "intended to be used by qualified and trained medical professionals, after proper installation."

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Details on experts or ground truth for a test set.
    4. Adjudication methods.
    5. MRMC comparative effectiveness study results.
    6. Standalone performance details.
    7. Type of ground truth used.
    8. Training set sample size.
    9. How training set ground truth was established.

    This document is a regulatory clearance and does not typically include the detailed technical study information you are asking for. That information would usually be found within the 510(k) submission itself, which is not provided in these pages.

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