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510(k) Data Aggregation

    K Number
    K981414
    Device Name
    LC POSITIONER
    Manufacturer
    FISCHER IMAGING CORP.
    Date Cleared
    1998-07-16

    (87 days)

    Product Code
    JAA
    Regulation Number
    892.1650
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LC POSITIONER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LC positioner is to be used as an accessory to a fluoroscopic unit for imaging the cardiovascular system.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding a device called the "LC Positioner (Fluoro C-Arm)". It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert evaluations.

    The letter primarily:

    • Confirms that the device is substantially equivalent to legally marketed predicate devices.
    • Classifies the device as Class II (21 CFR 892.1650/Procode: 90 JAA).
    • Outlines post-market regulatory requirements (e.g., general controls, GMP, labeling).

    Attachment A provides the device name and its intended use: "The LC positioner is to be used as an accessory to a fluoroscopic unit for imaging the cardiovascular system."

    Therefore, based solely on the provided text, I cannot answer the questions regarding acceptance criteria and device performance studies.

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