LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K051064
    Device Name
    ZIEHM QUANTUM
    Manufacturer
    ZIEHM IMAGING, INC.
    Date Cleared
    2005-05-26

    (30 days)

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

    ZIEHM QUANTUM

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

    The ZIEHM QUANTUM series Mobile C-Arm is intended for use in both Radiographic and Fluoroscopic applications. It is suitable for a wide variety of surgical intervention or guidance procedures requiring X-ray imaging - both inside and outside the operating room. These procedures include Cerebral, Thoracic, Vascular, Biliary, Abdominal, Orthopaedic, Peripheral, Embolization, Stent Placement, Urological Special Vascular-I flow Procedures, and other related fluoroscopic examinations requiring interventional procedures.

    The ZIEHM QUANTUM Mobile C-arms are also suitable as a back up for fixed-based X-ray Vascular and Intervention Procedures.

    Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.

    Device Description

    ZIEHM QUANTUM (Mobile x-ray system)

    AI/ML Overview

    The provided document is a 510(k) premarket notification approval letter from the FDA for a mobile x-ray system (ZIEHM QUANTUM). This type of document generally approves a device based on its substantial equivalence to a predicate device and does not typically contain detailed information about specific acceptance criteria or comprehensive study designs with the level of detail requested in the prompt (e.g., sample sizes for training/test sets, expert qualifications, adjudication methods for ground truth, MRMC studies, standalone performance).

    Therefore, based only on the provided text, it's not possible to describe the acceptance criteria and the study that proves the device meets those criteria with the requested level of detail. The document confirms the device's substantial equivalence to a predicate device for its stated indications for use, but it doesn't elaborate on the specific acceptance criteria or the specifics of studies conducted to demonstrate that equivalence.

    The document only states the "Indications for Use" for the ZIEHM QUANTUM, which is a description of how the device is intended to be used, not a set of performance acceptance criteria. It also mentions "Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier," which is a functional description, not a performance metric.

    Without more detailed study reports, an answer to your prompt cannot be fully generated from this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1