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510(k) Data Aggregation

    K Number
    K250689
    Device Name
    CloudTMS Edge
    Manufacturer
    TeleEMG, LLC
    Date Cleared
    2025-09-14

    (192 days)

    Product Code
    OBP
    Regulation Number
    882.5805
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251449
    Device Name
    BrainsWay Deep TMS System
    Manufacturer
    BrainsWay Ltd.
    Date Cleared
    2025-09-13

    (127 days)

    Product Code
    OBP
    Regulation Number
    882.5805
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251368
    Device Name
    FETOLY
    Manufacturer
    Diagnoly
    Date Cleared
    2025-09-12

    (134 days)

    Product Code
    IYN,IYO,QIH
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
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    K Number
    K252593
    Device Name
    LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)
    Manufacturer
    Boston Scientific Corporation
    Date Cleared
    2025-09-12

    (28 days)

    Product Code
    MXD
    Regulation Number
    870.1025
    Type
    Special
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250059
    Device Name
    BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)
    Manufacturer
    Becton, Dickinson and Company
    Date Cleared
    2025-09-12

    (245 days)

    Product Code
    ONB
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252189
    Device Name
    LED Light Therapy Mask (2311, 2344, 2457, 2458)
    Manufacturer
    Dongguan Yanxi Technology Co., Ltd.
    Date Cleared
    2025-09-12

    (60 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252595
    Device Name
    Stethophone Pro
    Manufacturer
    Sparrow Acoustics Inc.
    Date Cleared
    2025-09-12

    (28 days)

    Product Code
    DQD
    Regulation Number
    870.1875
    Type
    Special
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251518
    Device Name
    Volta AF-Xplorer II
    Manufacturer
    Volta Medical
    Date Cleared
    2025-09-12

    (119 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252562
    Device Name
    Spine & Trauma Navigation Instruments
    Manufacturer
    Brainlab AG
    Date Cleared
    2025-09-12

    (29 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250445
    Device Name
    Fast Warm - NX
    Manufacturer
    FUJIFILM Irvine Scientific
    Date Cleared
    2025-09-12

    (210 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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