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510(k) Data Aggregation

    K Number
    K252217
    Device Name
    CT VScore+
    Manufacturer
    Canon Medical Informatics, Inc.
    Date Cleared
    2025-11-28

    (136 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K250636
    Device Name
    Sophy Mini Monopressure Valve (SM1)
    Manufacturer
    Sophysa
    Date Cleared
    2025-11-28

    (270 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252658
    Device Name
    Medical Diode Laser Systems (TR-B)
    Manufacturer
    Baoding Te'Anzhou Electronic Technology Co., Ltd.
    Date Cleared
    2025-11-28

    (98 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253303
    Device Name
    Dendrite Imaging System
    Manufacturer
    Dendrite Imaging, Inc.
    Date Cleared
    2025-11-28

    (60 days)

    Product Code
    QDG
    Regulation Number
    878.4550
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252760
    Device Name
    Carriere® Motion Pro® Clear Bite Corrector
    Manufacturer
    Ortho Organizers, Inc.
    Date Cleared
    2025-11-27

    (90 days)

    Product Code
    DYW
    Regulation Number
    872.5470
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252388
    Device Name
    Vanquish Water Vapor Ablation Device
    Manufacturer
    Francis Medical, Inc.
    Date Cleared
    2025-11-26

    (118 days)

    Product Code
    KNS
    Regulation Number
    876.4300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K252000
    Device Name
    uDR Arria & uDR Aris
    Manufacturer
    Shanghai United Imaging Healthcare Co., Ltd.
    Date Cleared
    2025-11-26

    (152 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251697
    Device Name
    Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip
    Manufacturer
    Acon Laboratories, Inc.
    Date Cleared
    2025-11-26

    (177 days)

    Product Code
    GTY
    Regulation Number
    866.3740
    Type
    Dual Track
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253269
    Device Name
    OEC One CFD
    Manufacturer
    Ge Hualun Medical Systems Co. , Ltd.
    Date Cleared
    2025-11-26

    (58 days)

    Product Code
    OXO,JAA,OWB,QIH
    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
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    K Number
    K242976
    Device Name
    Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device
    Manufacturer
    Medical Wire & Equipment Company (Bath), Ltd.
    Date Cleared
    2025-11-26

    (426 days)

    Product Code
    JSM
    Regulation Number
    866.2390
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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