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510(k) Data Aggregation

    K Number
    K252500

    Validate with FDA (Live)

    Device Name
    CARA System
    Manufacturer
    Cara Medical, Ltd.
    Date Cleared
    2026-02-20

    (196 days)

    Product Code
    OWB
    Regulation Number
    892.1650
    Type
    Traditional
    Panel
    Radiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K252002

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    Device Name
    Monaco RTP System (6.3)
    Manufacturer
    Elekta Solutions AB
    Date Cleared
    2026-02-19

    (237 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K254018

    Validate with FDA (Live)

    Device Name
    Portable Dental X-ray Device (GT-1)
    Manufacturer
    Guilin Refine Medical Instrument Co., Ltd.
    Date Cleared
    2026-02-19

    (66 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Type
    Traditional
    Panel
    Radiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K260308

    Validate with FDA (Live)

    Device Name
    TrueFit Bolus
    Manufacturer
    Adaptiiv Medical Technologies, Inc.
    Date Cleared
    2026-02-19

    (20 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Type
    Special
    Panel
    Radiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
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    K Number
    K260205

    Validate with FDA (Live)

    Device Name
    AS Software Version Asera
    Manufacturer
    AS Software, LLC
    Date Cleared
    2026-02-19

    (27 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Special
    Panel
    Radiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K253564

    Validate with FDA (Live)

    Device Name
    uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
    Manufacturer
    Shanghai United Imaging Healthcare Co., Ltd.
    Date Cleared
    2026-02-13

    (88 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Type
    Traditional
    Panel
    Radiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K251992

    Validate with FDA (Live)

    Device Name
    ArmSure Fluoroscopic Positioning System
    Manufacturer
    Savfe Co. , Ltd.
    Date Cleared
    2026-02-11

    (229 days)

    Product Code
    OWB,JAA,LLZ
    Regulation Number
    892.1650
    Type
    Traditional
    Panel
    Radiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K253049

    Validate with FDA (Live)

    Device Name
    Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System
    Manufacturer
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
    Date Cleared
    2026-02-11

    (142 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    DEN250007

    Validate with FDA (Live)

    Device Name
    Delivery Date AI
    Manufacturer
    Ultrasound AI
    Date Cleared
    2026-02-11

    (331 days)

    Product Code
    SHE
    Regulation Number
    N/A
    Type
    Direct
    Panel
    Radiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K252084

    Validate with FDA (Live)

    Device Name
    AI4CMR v2.0
    Manufacturer
    Ai4medimaging Medical Solutions S.A.
    Date Cleared
    2026-02-11

    (224 days)

    Product Code
    QIH
    Regulation Number
    892.2050
    Type
    Special
    Panel
    Radiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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