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510(k) Data Aggregation

    K Number
    K011241
    Device Name
    NEUROSOFT'S SOURCE
    Manufacturer
    NEUROSOFT, INC.
    Date Cleared
    2001-09-19

    (149 days)

    Product Code
    OLX
    Regulation Number
    882.1400
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEUROSOFT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K001781
    Device Name
    CURRY MULTIMODAL NEUROIMAGING SOFTWARE
    Manufacturer
    NEUROSOFT, INC.
    Date Cleared
    2001-02-05

    (237 days)

    Product Code
    OLX
    Regulation Number
    882.1400
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEUROSOFT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

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    K Number
    K001692
    Device Name
    NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8
    Manufacturer
    NEUROSOFT, INC.
    Date Cleared
    2000-11-24

    (175 days)

    Product Code
    JXE,GWE,GWF,GWJ,IKN
    Regulation Number
    882.1550
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEUROSOFT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

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    K Number
    K000812
    Device Name
    NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE)
    Manufacturer
    NEUROSOFT, INC.
    Date Cleared
    2000-05-17

    (65 days)

    Product Code
    IKN
    Regulation Number
    890.1375
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEUROSOFT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

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