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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
    Why did this record match?
    Panel :

    Neurology (NE)

    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
    Why did this record match?
    Panel :

    Neurology (NE)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252576
    Device Name
    Legend X Platform
    Manufacturer
    Pollogen Ltd
    Date Cleared
    2025-09-12

    (29 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Special
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Neurology (NE)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251957
    Device Name
    Coaptium Connect with Tissium Light
    Manufacturer
    TISSIUM SA
    Date Cleared
    2025-09-08

    (75 days)

    Product Code
    SFD
    Regulation Number
    882.5270
    Type
    Special
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Neurology (NE)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250960
    Device Name
    DUO Microcatheter
    Manufacturer
    REV Neuro LLC
    Date Cleared
    2025-09-08

    (161 days)

    Product Code
    QJP,DQO,DQY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Neurology (NE)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    Device Description
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    K Number
    K251317
    Device Name
    SOLOPASS 2.0 System
    Manufacturer
    inTRAvent Medical Partners
    Date Cleared
    2025-09-05

    (129 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Neurology (NE)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251298
    Device Name
    Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)
    Manufacturer
    Clinical Laserthermia Systems AB
    Date Cleared
    2025-09-04

    (129 days)

    Product Code
    ONO
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Neurology (NE)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K243700
    Device Name
    Apollo TMS Therapy System
    Manufacturer
    MAG & More GmbH
    Date Cleared
    2025-09-04

    (279 days)

    Product Code
    OBP
    Regulation Number
    882.5805
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Neurology (NE)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    Device Description
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    K Number
    K250893
    Device Name
    Ball Joint Guide Array (66295)
    Manufacturer
    Bayer Medical Care, Inc.
    Date Cleared
    2025-09-04

    (163 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Neurology (NE)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K251909
    Device Name
    NeurotriS (SX2500); NeurotriS (SX3800)
    Manufacturer
    A-1 Engineering
    Date Cleared
    2025-09-03

    (75 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Neurology (NE)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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