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510(k) Data Aggregation

    K Number
    K172810
    Device Name
    PORT-X IV
    Manufacturer
    GENORAY Co., Ltd.
    Date Cleared
    2018-03-07

    (170 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K132041
    Why did this record match?
    Device Name :

    PORT-X IV

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

    PORT-X IV is a portable X-ray system to be used by trained dental technicians as a mobile, extra oral x-ray source for producing diagnostic x-ray images using intra oral image receptors. It is intended for both adult and pediativ subjects.

    Device Description

    The portable X-Ray system, PORT-X IV, is intended to be used by trained dentists and dental technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. It is the X-ray equipment and uses it to diagnose the patient to acquire images. It also includes accessories, which are battery, recharging unit and hand switch.

    AI/ML Overview

    The provided text is a 510(k) summary for the GENORAY Co., Ltd. PORT-X IV, a portable X-ray system. This document focuses on demonstrating substantial equivalence to a predicate device (Metabiomed, Inc. REXTAR X) rather than presenting a study to prove the device meets specific acceptance criteria for AI/algorithm performance. Therefore, many of the requested elements for an AI-based device's acceptance criteria and study are not applicable or cannot be extracted from this document.

    However, I will extract what is available regarding general device performance and safety.

    Here's the breakdown of the information based on the prompt and the provided text:

    1. A table of acceptance criteria and the reported device performance

    The document does not explicitly state "acceptance criteria" in a table format for AI performance. Instead, it details performance standards and safety criteria for an X-ray device based on federal and international standards.

    Acceptance Criteria (Standards and Requirements)Reported Device Performance (PORT-X IV)
    Safety and General Performance Standards
    IEC 60601-1 Series (Electrical, mechanical, environmental safety and performance)Complies with IEC 60601-1 Series. Electrical, mechanical, and environmental safety and performance testing performed. All test results were satisfactory.
    IEC 60601-1-3 (Radiological protection)Complies with IEC 60601-1-3. Radiological protection testing performed. All test results were satisfactory.
    IEC 60601-2-65 (Specific requirements for dental X-ray equipment)Complies with IEC 60601-2-65. Testing performed. All test results were satisfactory.
    IEC 60601-1-2 (EMC testing)EMC testing conducted in accordance with IEC 60601-1-2. All test results were satisfactory.
    Radiation Control Provisions (21 CFR 1020.30 & 1020.31)
    Focal spot to skin distance: Longer than minimum length of 18 cmConfirmed that the focal spot to skin distance was longer than the minimum length of 18 cm.
    Minimum HVL (half-value layer): 1.5 mmConfirmed that the minimum HVL was 1.5 mm.
    Accuracy of loading factors (e.g.,
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