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510(k) Data Aggregation

    K Number
    K063342
    Device Name
    MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS
    Manufacturer
    MEDRAD, INC.
    Date Cleared
    2006-11-30

    (24 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Special
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K051349
    Why did this record match?
    Reference Devices :

    K051349

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

    The eCoil Imaging System for Philips MR scanners is a receive-only coil intended for use as a Magnetic Resonance Diagnostic Device (MRDD) for high-resolution magnetic resonance imaging, including spectroscopy, of the human colon, cervix or prostate and surrounding pelvic tissue. The purpose of the interface device for the eCoil Imaging System is to provide interface and support functions to allow the use of MEDRAD disposable endorectal coils with Philips MRI scanner systems. Only trained healthcare professionals are intended to operate this device.

    Device Description

    The MEDRAD eCoil Imaging System maintains a similar intended use, similar operational parameters, similar labeling and is used in a manner similar to the predicate device. The eCoil Imaging System for Philips MRI scanners is a receive-only coil. The interface device provides interface and support functions to allow the use of MEDRAD disposable endorectal coils with Philips MRI scanner systems.

    AI/ML Overview

    The provided text is a 510(k) summary for the MEDRAD eCoil Imaging System for Philips. It describes the device's intended use and compares it to a predicate device. However, it does not contain information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as requested.

    Therefore, I cannot provide the requested table and details because the information is not present in the provided document.

    This document is a regulatory filing focused on demonstrating substantial equivalence to a legally marketed predicate device, not on presenting performance study results against specific acceptance criteria.

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