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510(k) Data Aggregation

    K Number
    K253489

    Validate with FDA (Live)

    Device Name
    Swoop® Portable MR Imaging® System
    Manufacturer
    Hyperfine, Inc.
    Date Cleared
    2025-12-12

    (49 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    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
    AI/ML Overview
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    K Number
    K252482

    Validate with FDA (Live)

    Device Name
    CogNet AI-MT+
    Manufacturer
    Medcognetics, Inc.
    Date Cleared
    2025-12-11

    (126 days)

    Product Code
    QFM
    Regulation Number
    892.2080
    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
    K251883

    Validate with FDA (Live)

    Device Name
    MIM – LesionID Pro
    Manufacturer
    Mim Software, Inc.
    Date Cleared
    2025-12-11

    (174 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
    AI/ML Overview
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    K Number
    K251199

    Validate with FDA (Live)

    Device Name
    Allia Moveo
    Manufacturer
    Ge Medical Systems Scs
    Date Cleared
    2025-12-09

    (235 days)

    Product Code
    OWB,IZI,JAA,OXO
    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
    AI/ML Overview
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    K Number
    K252294

    Validate with FDA (Live)

    Device Name
    Fetal EchoScan (v1.2)
    Manufacturer
    Brightheart
    Date Cleared
    2025-12-08

    (138 days)

    Product Code
    POK
    Regulation Number
    892.2060
    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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    K Number
    K251514

    Validate with FDA (Live)

    Device Name
    Overjet CBCT Assist
    Manufacturer
    Overjet, Inc.
    Date Cleared
    2025-12-05

    (203 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
    AI/ML Overview
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    K Number
    K252296

    Validate with FDA (Live)

    Device Name
    OncoPatch
    Manufacturer
    Oncopatch, Inc.
    Date Cleared
    2025-12-05

    (135 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    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
    K252498

    Validate with FDA (Live)

    Device Name
    Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU)
    Manufacturer
    Sonoscape Medical Corp
    Date Cleared
    2025-12-05

    (119 days)

    Product Code
    IYN,ITX,IYO
    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
    AI/ML Overview
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    K Number
    K250780

    Validate with FDA (Live)

    Device Name
    ARTAssistant
    Manufacturer
    Manteia Technologies Co., Ltd.
    Date Cleared
    2025-12-05

    (266 days)

    Product Code
    QKB
    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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    K Number
    K250791

    Validate with FDA (Live)

    Device Name
    ASUS Ultrasound Imaging System (LU800 series)
    Manufacturer
    Asustek Computer, Inc.
    Date Cleared
    2025-12-04

    (265 days)

    Product Code
    IYN,ITX,IYO
    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
    AI/ML Overview
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