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510(k) Data Aggregation

    K Number
    K203653
    Device Name
    MRI PPG Patient Cable
    Manufacturer
    Ivy Biomedical Systems, Inc.
    Date Cleared
    2021-03-02

    (77 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MRI PPG Patient Cable

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

    The MRI PPG Patient Cable is intended to connect to a parent device and facilitate the generation of continuous noninvasive peripheral pulse cardiac gating on adult, pediatric, and neonatal patients in hospital and/or health care environments.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter for the "MRI PPG Patient Cable" and contains "Indications for Use" information. It does not include details on acceptance criteria or a study proving that the device meets such criteria.

    The information provided describes the device's intended use and regulatory classification, but it does not delve into its performance metrics, how those metrics were evaluated, or any studies conducted to validate its performance against specific acceptance criteria.

    Therefore, I cannot provide the requested information based on the given text. The document focuses on regulatory clearance rather than technical performance validation.

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