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510(k) Data Aggregation

    K Number
    K011417
    Manufacturer
    Date Cleared
    2001-06-08

    (30 days)

    Product Code
    Regulation Number
    892.1560
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ULTRASOUND SCANNER, TYPE 2102

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K003986
    Manufacturer
    Date Cleared
    2001-04-03

    (98 days)

    Product Code
    Regulation Number
    892.1550
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ULTRASOUND SCANNER TYPE 2102

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K000567
    Manufacturer
    Date Cleared
    2000-03-09

    (16 days)

    Product Code
    Regulation Number
    892.1560
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ULTRASOUND SCANNER TYPE 2102

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

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