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510(k) Data Aggregation

    K Number
    K171184
    Device Name
    Persyst Mobile App
    Manufacturer
    Persyst Development Corporation
    Date Cleared
    2017-09-21

    (150 days)

    Product Code
    OMB,OLT,OMA
    Regulation Number
    882.1400
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Persyst Mobile App

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

    1. The Persyst Mobile App is a software application that can be executed on a mobile platform. It is capable of displaying the original EEG data, and quantitative analysis of EEG data generated by the Persyst EEG Review and Analysis Software. This Mobile App is intended to be used by qualified medical practitioners who will exercise professional judgement in using the information.

    2. This device does not provide any diagnostic conclusion about the patient's condition to the user.

    Device Description

    The Persyst Mobile App is a software application that can be executed on a mobile platform. It is capable of displaying the original EEG data, and quantitative analysis of EEG data generated by the Persyst EEG Review and Analysis Software.

    AI/ML Overview

    The provided text is a 510(k) clearance letter for the Persyst Mobile App, which is software for displaying and analyzing EEG data. It does not contain information about specific acceptance criteria, a study proving those criteria were met, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established.

    The document states:

    • Device Name: Persyst Mobile App
    • Indications for Use:
      1. A software application executable on a mobile platform.
      2. Capable of displaying original EEG data and quantitative analysis of EEG data generated by Persyst EEG Review and Analysis Software.
      3. Intended for use by qualified medical practitioners who will exercise professional judgment.
      4. Does not provide any diagnostic conclusion about the patient's condition to the user.
    • Regulation Number: 21 CFR 882.1400 (Electroencephalograph)
    • Regulatory Class: Class II

    Because this is a 510(k) clearance letter, it confirms substantial equivalence to a predicate device. It does not typically detail the specific performance validation studies that would contain the requested information about acceptance criteria or study methodologies. Such details would usually be found in the 510(k) submission itself, which is not included here. Therefore, I cannot provide the requested information from the given text.

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