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    K Number
    DEN240074
    Device Name
    Pulsenmore ES
    Manufacturer
    Pulsenmore Ltd.
    Date Cleared
    2025-10-31

    (324 days)

    Product Code
    SGJ
    Regulation Number
    N/A
    Type
    Direct
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K252074
    Device Name
    Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System
    Manufacturer
    Canon Medical Systems Corporation
    Date Cleared
    2025-10-31

    (121 days)

    Product Code
    IYN,ITX,IYO,QIH
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250337
    Device Name
    AiORTA - Plan
    Manufacturer
    ViTAA Medical Solutions Inc.
    Date Cleared
    2025-10-30

    (266 days)

    Product Code
    QIH
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K251985
    Device Name
    LOGIQ E10
    Manufacturer
    GE Medical Systems Ultrasound and Primary Care Diagnostics
    Date Cleared
    2025-10-29

    (124 days)

    Product Code
    IYN,ITX,IYO,QIH
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K253242
    Device Name
    LCD Monitor (C1216W, C822W, C821W)
    Manufacturer
    Shenzhen Beacon Display Technology Co., Ltd.
    Date Cleared
    2025-10-29

    (30 days)

    Product Code
    PGY
    Regulation Number
    892.2050
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K251963
    Device Name
    LOGIQ E10s
    Manufacturer
    GE Medical Systems Ultrasound and Primary care Diagnostics,
    Date Cleared
    2025-10-29

    (125 days)

    Product Code
    IYN,ITX,IYO,QIH
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K252547
    Device Name
    TheraSphere 360™ Y-90 Management Platform
    Manufacturer
    Boston Scientific Corporation
    Date Cleared
    2025-10-28

    (77 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K251027
    Device Name
    cvi42 Coronary Plaque Software Application
    Manufacturer
    Circle Cardiovascular Imaging Inc.
    Date Cleared
    2025-10-27

    (208 days)

    Product Code
    QIH
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251827
    Device Name
    Azurion R3.1
    Manufacturer
    Philips Medical Systems B.V.
    Date Cleared
    2025-10-24

    (133 days)

    Product Code
    OWB
    Regulation Number
    892.1650
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K251059
    Device Name
    Syngo Carbon Clinicals (VA41)
    Manufacturer
    Siemens Healthineers AG
    Date Cleared
    2025-10-24

    (203 days)

    Product Code
    QIH,LLZ,MUJ,OEB
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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