LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K981267
    Device Name
    FACTS MONOBLOCK
    Manufacturer
    DYNARAD CORP.
    Date Cleared
    1998-05-06

    (29 days)

    Product Code
    IZX,ITY,IZO
    Regulation Number
    892.1610
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FACTS MONOBLOCK

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

    General Purpose Fluoroscope Applications

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes a 510(k) clearance letter from the FDA for a device called "Facts Monoblock Diagnostic X-Ray Tube Housing Assembly." This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided document does not contain any information about acceptance criteria, device performance, study details (sample sizes, ground truth, expert qualifications, etc.), or specific comparative effectiveness studies.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them because this information is not present in the given text. The document is solely a regulatory clearance letter acknowledging substantial equivalence based on prior submissions, not a scientific study report.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1