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510(k) Data Aggregation

    K Number
    K253363

    Validate with FDA (Live)

    Device Name
    NeuroSpan Bridge
    Manufacturer
    Auxilium Biotechnologies, Inc.
    Date Cleared
    2026-01-17

    (109 days)

    Product Code
    JXI
    Regulation Number
    882.5275
    Type
    Traditional
    Panel
    Neurology
    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
    K251970

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    Device Name
    Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
    Manufacturer
    Medtronic, Ireland
    Date Cleared
    2026-01-17

    (205 days)

    Product Code
    LOX
    Regulation Number
    870.5100
    Type
    Traditional
    Panel
    Cardiovascular
    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
    K251739

    Validate with FDA (Live)

    Device Name
    da Vinci Surgical System (IS5000)
    Manufacturer
    Intuitive Surgical, Inc.
    Date Cleared
    2026-01-16

    (224 days)

    Product Code
    NAY
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    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
    K251353

    Validate with FDA (Live)

    Device Name
    Eyer 2
    Manufacturer
    Phelcom Technologies
    Date Cleared
    2026-01-16

    (261 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Type
    Traditional
    Panel
    Ophthalmic
    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
    K251934

    Validate with FDA (Live)

    Device Name
    qXR-Detect
    Manufacturer
    Qure.Ai Technologies
    Date Cleared
    2026-01-16

    (206 days)

    Product Code
    MYN
    Regulation Number
    892.2070
    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
    K253556

    Validate with FDA (Live)

    Device Name
    da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator
    Manufacturer
    Intuitive Surgical, Inc.
    Date Cleared
    2026-01-16

    (63 days)

    Product Code
    NAY
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    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
    K253082

    Validate with FDA (Live)

    Device Name
    LZI Buprenorphine II Enzyme Immunoassay
    Manufacturer
    Lin-Zhi International, Inc.
    Date Cleared
    2026-01-16

    (115 days)

    Product Code
    DJG
    Regulation Number
    862.3650
    Type
    Traditional
    Panel
    Toxicology
    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
    K252767

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    Device Name
    actiTENS mini
    Manufacturer
    Sublimed
    Date Cleared
    2026-01-16

    (140 days)

    Product Code
    GZJ,IPF,NGX,NUH,NYN
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    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
    K252775

    Validate with FDA (Live)

    Device Name
    NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg
    Manufacturer
    Hycor Biomedical
    Date Cleared
    2026-01-16

    (136 days)

    Product Code
    DHB
    Regulation Number
    866.5750
    Type
    Traditional
    Panel
    Immunology
    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
    K252634

    Validate with FDA (Live)

    Device Name
    Imagine® Enterprise Suite
    Manufacturer
    Softlink International Private Limited
    Date Cleared
    2026-01-16

    (149 days)

    Product Code
    QIH
    Regulation Number
    892.2050
    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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