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510(k) Data Aggregation

    K Number
    K090655
    Device Name
    PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260
    Manufacturer
    SOURCE-RAY, INC.
    Date Cleared
    2009-07-14

    (125 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260

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

    The Model PowerMax 1260 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication method, MRMC study, standalone performance), or training set information. The document is an FDA 510(k) clearance letter for the "PowerMax 1260 Portable X-Ray System," primarily confirming its substantial equivalence to predicate devices and outlining regulatory requirements. It includes an "Indications for Use" form, but this does not provide the specific details you requested regarding performance studies.

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