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510(k) Data Aggregation

    K Number
    K153593
    Device Name
    CliniscanSM MRI
    Manufacturer
    Date Cleared
    2016-02-17

    (63 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    PICOFEMTO LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    1. CliniscanSM MRI is intended for automatic labeling, visualization and volumetric quantification of segmented brain structures from a set of MRI images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmental brain structures identified on MR images. 2. This software is intended for use on adult patients only (18+ years). 3. CliniscanSM MRI is NOT intended to diagnose, treat, cure or prevent any disease. All results must be reviewed by a qualified healthcare professional prior to any diagnosis.
    Device Description
    Not Found
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    K Number
    K141883
    Device Name
    CLINISCANSM EEG
    Manufacturer
    Date Cleared
    2015-05-15

    (308 days)

    Product Code
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    PICOFEMTO LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    1. CliniscanSM EEG is a clinical decision support system for medical data, to assist healthcare professionals in the visualization and analysis of EEG data. 2. The Seizure Detection component of CliniscanSM EEG is intended to mark previously acquired sections of adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. 3. CliniscanSM EEG is intended for use on EEG recordings acquired using full scalp montage according to the standard 10/20 system. 4. The user may annotate the data, and the annotations are stored with the EEG recording in the cloud. 5. CliniscanSM EEG displays standard qEGG features to the user including FFT Power Spectrum. Coherence Mapping (EEG Activity Mapping), Density Spectral Array, EEG Localization Maps, and Wavelet Subband Decomposition (Delta, Theta, Alpha, Beta, and Gamma). 6. CliniscanSM EEG detects seizure events for review by qualified medical professionals. 7. CliniscanSM EEG is designed to provide analytics data derived from a patient's input EEG data. It is NOT designed to provide definitive diagnoses of diseases or treatments of ailments.
    Device Description
    Cliniscan®M EEG, a Picofemto product, is a clinical decision support system for medical data, designed to assist healthcare professionals in the visualization and analysis of EEG data. The device provides seizure event detection and calculates many qEEG (quantitative EEG) parameters for display to the user. All analysis (seizure detection and qEEG) are displayed in conjunction with the original EEG recording for review by experts and are designed to be reviewed in the context of the original data. The Cliniscan®% EEG visualizer provides a user-friendly environment for displaying the available qEEG parameters along with the original EEG recording (see below). The EEG recording display window, time bar, and User Annotations frames remained fixed within the visualizer; however, the bottom portion of the screen contains tabs for the user to navigate the qEEG features. The user may access the FFT Power Spectrum, Coherence Maps, and EEG Topography Maps under the "Combo" tab; Wavelet Subband Decomposition and the FFT Power Spectrum (again) are located under the "Power" tab; the "DSA" tab contains only the Density Spectral Array display. After uploaded an EEG in EDF format, the user may view the following qEEG Parameters: 1) FFT Power Spectrum 2) Coherence Maps 3) EEG Topographical Maps 4) Wavelet Subband Decomposition 5) Density Spectral Array (DSA) 6) User Annotations 7) Seizure Event Detection 8) Info Cliniscan®ª EEG is designed to provide industry standard analytics data derived from a patient's input EEG data. It is NOT designed to provide definitive diagnoses of diseases or treatments of ailments. Cliniscan§™ EEG detects and marks possible seizure events on previously acquired EEG recordings for review by qualified medical professionals.
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