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510(k) Data Aggregation

    K Number
    K081304
    Device Name
    ALZ WEB PACS, VERSION 1.0
    Manufacturer
    ALZ, INC.
    Date Cleared
    2008-06-11

    (34 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K020995,K023476
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALZ, INC.

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

    ALZ Web PACS (Version 1.0) is an imaging software system intended to be used by trained healthcare professionals. ALZ Web PACS is used with general purpose computing hardware to acquire, transmit, store, view, and process DICOM images.

    This device is not intended for mammography.

    Device Description

    The ALZ Web PACS (Version 1.0) is designed for the management, viewing, and processing of DICOM images. The ALZ Web PACS consists of the ALZ Web PACS software application installed on a server and the ALZ Web PACS viewer running on client computers connecting to the server via the HTTPS protocol.

    AI/ML Overview

    The provided text does not contain any information about specific acceptance criteria, detailed study designs, or performance metrics for the ALZ Web PACS (Version 1.0) beyond a general statement that "The ALZ Wcb PACS was tested to verify that the device meets prospectively defined design and performance specifications. The results of the testing confirmed that the ALZ Web PACS performed as intended."

    Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

    The document is a 510(k) summary for a Picture Archiving and Communication System (PACS), which typically involves verification and validation activities related to software functionality, compatibility with DICOM standards, and overall system reliability rather than diagnostic performance against a ground truth for a specific medical condition.

    If this were a device with specific diagnostic claims, the 510(k) would contain a much more comprehensive description of performance testing, including sensitivity, specificity, accuracy, and detailed study parameters. For a PACS, the "performance testing" referenced is likely focused on:

    • Functional Testing: Ensuring all described features (acquiring, transmitting, storing, viewing, processing DICOM images) work as intended.
    • Compatibility Testing: Verifying interoperability with various DICOM-compliant modalities and other systems.
    • Performance and Load Testing: Assessing speed and reliability under expected usage conditions.
    • Security Testing: Ensuring data integrity and patient privacy.
    • Usability Testing: Confirming ease of use for trained healthcare professionals.

    Without specific details in the provided text, I can only state that the document indicates that performance testing was conducted, and the device met its defined specifications, but no further details are given.

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