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510(k) Data Aggregation

    K Number
    K042041
    Device Name
    XPLORER 1600
    Manufacturer
    IMAGING DYNAMICS COMPANY LIMITED
    Date Cleared
    2004-09-17

    (50 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMAGING DYNAMICS COMPANY LIMITED

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

    The Xplorer 1600 is intended for use by a qualified/trained doctor or technologist on both adult and pedial.inc patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremilies, and other body parts but not mammography. Applications can be performed with patient sitting, standing or lying in the prone or supine positions.

    Device Description

    A stationary x-ray system with CCD imager

    AI/ML Overview

    This is a 510(k) clearance letter for an X-ray system, specifically the Xplorer 1600. The provided document is a letter from the FDA regarding substantial equivalence and the "Indications for Use" statement. It does not contain information about acceptance criteria or a study proving that the device meets those criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.

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