LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K991626
    Device Name
    WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION
    Manufacturer
    ANALOGIC CORP.
    Date Cleared
    1999-07-02

    (52 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The WebRad Computed Radiography Quality Assurance (CR/QA) Workstation is a Web based software product that will aid with and connect to computed radiography images acquired from a FUJI Computed Radiography system, other modalities, film digitizers and image phosphor plate scanners.

    Device Description

    WEBRAD Computed Radiography Quality Assurance (CR/QA) Workstation

    AI/ML Overview

    I am sorry, but the provided text does not contain the acceptance criteria or a study that proves the device meets specific criteria. The document is an FDA 510(k) clearance letter for the WEBRAD Computed Radiography Quality Assurance Workstation, indicating that the device has been found substantially equivalent to legally marketed predicate devices.

    The text does not provide information on:

    • A table of acceptance criteria or reported device performance.
    • Sample size, data provenance, number or qualifications of experts for ground truth, or adjudication methods for a test set.
    • Details about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
    • Standalone algorithm performance.
    • Type of ground truth used in any study.
    • Sample size for training sets or how their ground truth was established.

    The document primarily states the device's clearance and its intended use, which is a web-based software product to assist with the acquisition, management, and viewing of computed radiography images.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1