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510(k) Data Aggregation

    K Number
    K132770
    Device Name
    DOME S10
    Manufacturer
    NDS SURGICAL IMAGING
    Date Cleared
    2014-01-30

    (148 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K093197
    Why did this record match?
    Device Name :

    DOME S10

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Model S10 is intended for use in displaying and viewing radiography images for review and analysis by trained medical practitioners, and for use in mammography display systems.

    Device Description

    The Dome S10 is a widescreen 30-inch 10 megapixel grayscale diagnostic monitor. Its sleek design and high brightness makes the S10 ideal for viewing full field digital mammography and allow it to show two 5MP images for back-to-back chest wall reads.

    AI/ML Overview

    The provided document is a 510(k) summary for the Dome S10 Color Monitor, a medical display device. It focuses on establishing substantial equivalence to a predicate device rather than presenting a study demonstrating the device's performance against specific acceptance criteria for diagnostic accuracy.

    Therefore, the document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 regarding a study proving the device meets acceptance criteria for diagnostic performance.

    The document primarily states:

    • Intended Use: The Model S10 is intended for use in displaying and viewing radiography images for review and analysis by trained medical practitioners, and for use in mammography display systems. (Page 1, Section L & Page 4)
    • Substantial Equivalence: The Dome S10 is substantially equivalent to the predicate device K093197 Coronis Fusion 10MP (MDCG-10130). Both devices have the same indication for use with the same characteristics. Both devices use the same technology and use displays with the same resolution, same number of colors, same refresh rate, same maximum brightness, and the same pixel rise/fall times. (Page 0, Section J)
    • Safety Standards: Based upon test results, the model S10 radiology display meets IEC/EN60601-1 and 60601-1-2 standards which establish its safe design and operation. (Page 1, Section N)

    In summary, this submission is for a display monitor, and the "acceptance criteria" discussed are related to technical specifications and regulatory compliance for substantial equivalence to an existing monitor, not diagnostic performance of an AI algorithm.

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