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510(k) Data Aggregation

    K Number
    K062405
    Device Name
    XPLORER 1590
    Manufacturer
    IMAGING DYNAMICS COMPANY LTD.
    Date Cleared
    2006-09-13

    (29 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    XPLORER 1590

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

    The Xplorer 1590 Digital Radiographic System with motorized stand (510k submission device) is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. The Xplorer 1590 (510k submission device) is not intended for mammography.

    Device Description

    Xplorer 1590 Digital Radiographic System with Motorized Stand

    AI/ML Overview

    I am sorry, but the provided text does not contain the required information to describe the acceptance criteria and study proving device performance. The document is an FDA 510(k) clearance letter for a device called "Xplorer 1590 Digital Radiographic System with Motorized Stand." It confirms the device's substantial equivalence to a predicate device but does not detail acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

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