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510(k) Data Aggregation

    K Number
    K050621
    Device Name
    NVA-127-8-A NEUROVASCULAR ARRAY COIL
    Manufacturer
    MRI DEVICES CORPORATION
    Date Cleared
    2005-04-07

    (28 days)

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

    NVA-127-8-A NEUROVASCULAR ARRAY COIL

    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 when interpreted by a trained physician.

    Device Description

    Model NVA-127-8-A Neurovascular Array Coil

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter for a Magnetic Resonance (MR) diagnostic device. It does not contain information about acceptance criteria or a study proving device performance as requested in the prompt. The letter confirms substantial equivalence to a predicate device but does not detail performance data, sample sizes, expert qualifications, or ground truth methodologies.

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