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510(k) Data Aggregation

    K Number
    K233126
    Device Name
    aetherSlide
    Manufacturer
    aetherAI Co., Ltd.
    Date Cleared
    2024-05-30

    (246 days)

    Product Code
    QKQ
    Regulation Number
    864.3700
    Why did this record match?
    Applicant Name (Manufacturer) :

    aetherAI Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For In Vitro Diagnostic Use aetherSlide is a software-only device intended for viewing and managing digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret and manage digital images of pathology slides for primary diagnosis. aetherSlide is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. aetherSlide is intended for use with the Philips Ultra Fast Scanner (UFS) and the Philips PS27QHDCR monitor.
    Device Description
    aetherSlide, version 101692 is a web-based, software only device that is intended to aid pathology professionals in viewing, interpretation and management of digital whole slide images (WSI) of scanned surgical pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue obtained from Philips Ultra Fast Scanner (UFS). It aids the pathologist in the review, interpretation, and management of pathology slide digital images used to generate a primary diagnosis.
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