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510(k) Data Aggregation

    K Number
    K963953
    Device Name
    IMIG-MRI
    Manufacturer
    IMIG-MRI SYSTEMS, LLC.
    Date Cleared
    1996-12-18

    (77 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K982157,K983902
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Anatomy: head, limbs, spine, torso; Nuclei: H-1; Diagnostic uses: Imaging

    Device Description

    Magnetic Resonance Diagnostic Device.

    AI/ML Overview

    Here's an analysis of the provided text regarding the IMIG-MRI device, focusing on acceptance criteria and study details.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific MetricAcceptance Criteria (Head Coil)Reported Device Performance (Head Coil)Acceptance Criteria (Body Coil)Reported Device Performance (Body Coil)
    Signal-to-Noise Ratio (S/N)S/N> 32> 32 (implied, no specific value given)> 31> 31 (implied, no specific value given)
    UniformityUniformity
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