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510(k) Data Aggregation

    K Number
    K253405

    Validate with FDA (Live)

    Device Name
    Prana System
    Manufacturer
    Prana Surgical
    Date Cleared
    2026-04-01

    (183 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    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
    K252513

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    Device Name
    Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)
    Manufacturer
    Poly Medicure Limited
    Date Cleared
    2026-04-01

    (233 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Type
    Special
    Panel
    General Hospital
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K253654

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    Device Name
    IntelliVue Measurement Rack 6000 (867317)
    Manufacturer
    Philips Medizin Systeme Böblingen GmbH
    Date Cleared
    2026-03-30

    (130 days)

    Product Code
    N/A
    Regulation Number
    N/A
    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
    K253595

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    Device Name
    EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
    Manufacturer
    Philips Ultrasound, LLC
    Date Cleared
    2026-03-27

    (129 days)

    Product Code
    IYN,ITX,IYO,OBJ,QIH
    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
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    K Number
    K253649

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    Device Name
    Spectral CT Verida Family
    Manufacturer
    Philips Medical Systems Technologies , Ltd.
    Date Cleared
    2026-03-27

    (127 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    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
    K252992

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    Device Name
    CT Rembra RT; CT Areta RT; CT Rembra
    Manufacturer
    Philips Healthcare (Suzhou) Co., Ltd.
    Date Cleared
    2026-03-23

    (186 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    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
    K260519

    Validate with FDA (Live)

    Device Name
    Smart Fit TorsoCardiac 1.5T
    Manufacturer
    Philips Healthcare (Suzhou) Co., Ltd.
    Date Cleared
    2026-03-20

    (31 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    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
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    K Number
    K253886

    Validate with FDA (Live)

    Device Name
    Grappler Suture Anchor PCFD Tether System
    Manufacturer
    Paragon 28, Inc.
    Date Cleared
    2026-03-17

    (103 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    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
    K253614

    Validate with FDA (Live)

    Device Name
    EchoNavigator R5.0
    Manufacturer
    Philips Medical Systems Nederland B.V.
    Date Cleared
    2026-03-17

    (119 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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    K Number
    K253590

    Validate with FDA (Live)

    Device Name
    Millipede System
    Manufacturer
    Perfuze, Ltd.
    Date Cleared
    2026-03-16

    (119 days)

    Product Code
    NRY
    Regulation Number
    870.1250
    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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