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510(k) Data Aggregation

    K Number
    K023729
    Device Name
    SIASCOPE II
    Date Cleared
    2003-02-03

    (89 days)

    Product Code
    Regulation Number
    878.4580
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SIASCOPE II

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

    SIAscope is a non-invasive skin analysis system, which provides a synthesized 'image' showing the relative location of blood collagen and pigment.

    Device Description

    SIAscope is a non-invasive skin analysis system.

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a device called SIAscope II. The letter primarily addresses the substantial equivalence determination and regulatory compliance. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request based on the given input.

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