LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K021570
    Device Name
    HNC-127-TRIO NEUROVASCULAR ARRAY COIL
    Manufacturer
    MRI DEVICES CORP.
    Date Cleared
    2002-06-12

    (29 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head and neck, that can be interpreted by a trained physician.

    Device Description

    HNC-127-TRIO Neurovascular Array Coil

    AI/ML Overview

    This document is a marketing authorization letter from the FDA for a medical device. It does not contain information about acceptance criteria, study details, performance metrics, sample sizes, expert qualifications, or ground truth establishment for an AI/ML device.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is about the regulatory clearance of a neurovascular array coil, a physical medical device, not an AI/ML algorithm.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1