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510(k) Data Aggregation

    K Number
    K251881

    Validate with FDA (Live)

    Device Name
    HippoMind (v1.0)
    Manufacturer
    Hippoclinic
    Date Cleared
    2025-12-03

    (168 days)

    Product Code
    OLT,LLZ,OLY,OMA
    Regulation Number
    882.1400
    Type
    Traditional
    Panel
    Neurology
    Age Range
    All
    Reference & Predicate Devices
    K200878,K172490,K030737
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HippoMind is a software application that displays neuroimaging and neurosignaling data for review by a health care provider. It provides simple tools for analysis of both medical images and EEG/MEG data. It also allows for storage and transfer of data, and association of data with electronic health records. It is intended for use by qualified health care professionals.

    Device Description

    HippoMind is a cloud-based software platform designed for neurologists and neurodiagnostic technologists to review neurophysiological and neuroimaging data. It provides secure, remote access to patient data, through an intuitive interface, to support clinical decision-making.

    The platform includes two main modules:

    Neurophysiological signal platform: This module enables the review of EEG and MEG data with customizable settings such as amplitude, filtering, and channel templates. It features a labeling system to annotate events, and advanced signal visualization with topological energy graphs. The platform supports Natus EEG, EDF, and CTF MEG formats.

    Neuroimaging Review Platform: This module displays 3D MRI, CT, PET, and SPECT images in DICOM or NiFTI format. It offers flexible viewing options, including 3D rendering, customizable color schemes, annotation tools, and an overlay system to superimpose imaging modalities (e.g., T1 and T2 images) using affine transformation.

    AI/ML Overview

    N/A

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