LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K180989
    Device Name
    PEDRA-17F Digital Flat Panel X-ray Detector
    Manufacturer
    Radisen Inc.
    Date Cleared
    2018-06-13

    (58 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K221144
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PEDRA-17F detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general-purpose diagnostic procedures. It is not to be used for mammography.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) letter for the PEDRA-17F Digital Flat Panel X-ray Detector does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment related to an AI/ML-driven device.

    This document is a standard 510(k) clearance letter for a digital flat panel X-ray detector, which is a hardware device for capturing X-ray images, not an AI/ML software device for image analysis. The letter focuses on the substantial equivalence of the hardware device to existing predicate devices based on its indications for use and general controls.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them using the provided text. The information required for your request (e.g., acceptance criteria for diagnostic accuracy, sample sizes for AI model validation, expert qualifications for ground truth, etc.) is not present in this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1