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510(k) Data Aggregation

    K Number
    K153283
    Device Name
    VivoSight Dx Topical OCT System
    Manufacturer
    Michelson Diagnostics Ltd
    Date Cleared
    2016-08-11

    (273 days)

    Product Code
    NQQ
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Michelson Diagnostics Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VivoSight Dx is a Multi-Beam Optical Coherence Tomography (OCT) system indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body.
    Device Description
    VivoSight Dx is a Multi-Beam Optical Coherence Tomography (OCT) system.
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    K Number
    K093520
    Device Name
    VIVOSIGHT TOPICAL OCT SYSTEM
    Manufacturer
    MICHELSON DIAGNOSTICS LTD.
    Date Cleared
    2010-01-05

    (53 days)

    Product Code
    NQQ, NOQ
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICHELSON DIAGNOSTICS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VivoSight is a Multi-Beam Optical Coherence Tomography (OCT) system indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body.
    Device Description
    Multi-Beam Optical Coherence Tomography (OCT) tissue imaging system
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