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510(k) Data Aggregation

    K Number
    K980279
    Device Name
    SONY DXC-LS1 COLOR VIDEO CAMERA
    Manufacturer
    SONY MEDICAL ELECTRONICS CO.
    Date Cleared
    1998-04-24

    (88 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K884343
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Sony DXC-LS1 Color Video Camera is intended for use in capturing video images for display and storage in applications such as surgery, microsurgery, endoscopy, dentistry and microscopy.

    Device Description

    The Sony DXC-LS1 is a progression in the DXC line of cameras. The DXC-LS1 is designed specifically for applications where space is limited. A comprehensive system of adaptors, lenses, cables and other accessories is available. These accessories enable the camera to be used in various medical applications including surgery, microsurgery, endoscopy, dentistry and microscopy, and other general medical procedures involving reproduction of video images.

    AI/ML Overview

    The provided text is a 510(k) summary for the Sony DXC-LS1 Color Video Camera. It focuses on establishing substantial equivalence to predicate devices. It does not contain the detailed information required to describe acceptance criteria for device performance or a study demonstrating that the device meets those criteria.

    Specifically, the document discusses:

    • Predicate devices: Sony DXC-750MD and DXC-101/102 Series Color Video Cameras.
    • Technological characteristics: States the DXC-LS1 has higher resolution and a smaller size, and uses Hyper HAD technology.
    • Intended use: Capturing video images for display and storage in medical applications like surgery, microsurgery, endoscopy, dentistry, and microscopy.

    The document does NOT provide information on:

    1. Acceptance criteria and reported device performance: It doesn't list specific performance metrics (e.g., resolution targets, signal-to-noise ratio, color accuracy) or quantitative results.
    2. Sample size for test set and data provenance.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study.
    6. Standalone (algorithm only) performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    This 510(k) summary is a regulatory submission to demonstrate equivalence, not a detailed technical study report comparing performance against specific acceptance criteria. Therefore, I cannot construct the table or provide the requested study details from the provided text.

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