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510(k) Data Aggregation

    K Number
    K011273
    Device Name
    SI ASCOPE
    Manufacturer
    ASTRON CLINICA LIMITED
    Date Cleared
    2002-02-20

    (300 days)

    Product Code
    PSN
    Regulation Number
    878.4580
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SI ASCOPE

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

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

    Device Description

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

    AI/ML Overview

    I apologize, but the provided text only contains an FDA 510(k) clearance letter for a device called "SIAscope." This letter confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory information.

    However, it does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications. Therefore, I am unable to provide the detailed answer you requested based solely on the provided input.

    To answer your questions, I would need access to the actual 510(k) submission summary or a separate study report for the SIAscope device.

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