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510(k) Data Aggregation

    K Number
    K024352
    Device Name
    HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM
    Manufacturer
    MRI DEVICES CORP.
    Date Cleared
    2003-01-09

    (10 days)

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

    HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM

    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, that can be interpreted by a trained physician.

    Device Description

    Model HRH-127-8 Head Array Coil for the GE Signa 3T Excite MRI System

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for an MRI head coil (HRH-127-8 Head Array Coil for GE Signa 3T Excite MRI System). This type of document is an approval for a medical device that demonstrates substantial equivalence to a legally marketed predicate device.

    The letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

    Therefore, I cannot provide the requested information based on this document. The document primarily focuses on the regulatory approval process and states that the device is substantially equivalent to existing devices for producing diagnostic images of the head. It does not detail the specific performance metrics or studies used to demonstrate this equivalence.

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