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510(k) Data Aggregation

    K Number
    K061952
    Device Name
    CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16
    Manufacturer
    INVIVO
    Date Cleared
    2006-07-28

    (18 days)

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

    CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16

    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 cardiovascular, pulmonary, renal, and abdominal systems that can be interpreted by a trained physician.

    Device Description

    Models CAC-63-16, CAC-63-32, CAC-123-32, & CAC-127-16 Cardiovascular Array Coils

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a medical device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms that the device, Invivo Corporation's Cardiovascular Array Coils, is substantially equivalent to a legally marketed predicate device.

    Therefore, I cannot provide the requested information based on the provided text.

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