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510(k) Data Aggregation

    K Number
    K253625

    Validate with FDA (Live)

    Device Name
    Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
    Manufacturer
    Canon Medical Systems Corporation
    Date Cleared
    2026-03-27

    (129 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    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
    K252037

    Validate with FDA (Live)

    Device Name
    CUVIS-joint (CJ150)
    Manufacturer
    Curexo, Inc.
    Date Cleared
    2026-03-25

    (268 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    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
    K253834

    Validate with FDA (Live)

    Device Name
    VISUREF 600
    Manufacturer
    Carl Zeiss Vision GmbH
    Date Cleared
    2026-03-18

    (107 days)

    Product Code
    HJO
    Regulation Number
    886.1850
    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
    K252078

    Validate with FDA (Live)

    Device Name
    BreathePal Bilevel (GFM50-MD2201)
    Manufacturer
    Compal Electronics, Inc.
    Date Cleared
    2026-03-17

    (258 days)

    Product Code
    MNS
    Regulation Number
    868.5895
    Type
    Traditional
    Panel
    Anesthesiology
    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
    K253587

    Validate with FDA (Live)

    Device Name
    Cala kIQ Plus
    Manufacturer
    Cala Health, Inc.
    Date Cleared
    2026-03-17

    (120 days)

    Product Code
    QBC
    Regulation Number
    882.5897
    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
    K252971

    Validate with FDA (Live)

    Device Name
    Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
    Manufacturer
    C.R. Bard, Inc.
    Date Cleared
    2026-03-17

    (181 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    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
    K254045

    Validate with FDA (Live)

    Device Name
    CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System
    Manufacturer
    CarboFix Orthopedics , Ltd.
    Date Cleared
    2026-03-16

    (89 days)

    Product Code
    NKG
    Regulation Number
    888.3075
    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
    K260078

    Validate with FDA (Live)

    Device Name
    Aquilion ServeSP (TSX-307B) V2.0
    Manufacturer
    Canon Medical Systems Corporation
    Date Cleared
    2026-03-13

    (60 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
    K253205

    Validate with FDA (Live)

    Device Name
    OptiMap Catheter - 50mm (OPTI-CATH2-50)
    Manufacturer
    Cortex, Inc.
    Date Cleared
    2026-03-13

    (168 days)

    Product Code
    MTD
    Regulation Number
    870.1220
    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
    K253185

    Validate with FDA (Live)

    Device Name
    Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System
    Manufacturer
    Carestream Health
    Date Cleared
    2026-03-11

    (166 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    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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