LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K190332
    Device Name
    Aperio AT2 DX System
    Manufacturer
    Leica Biosystems Imaging, Inc.
    Date Cleared
    2019-05-20

    (95 days)

    Product Code
    PSY
    Regulation Number
    864.3700
    Type
    Traditional
    Panel
    Pathology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Aperio AT2 DX System

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

    The Aperio AT2 DX System is an automated digital slide creation and viewing system. The Aperio AT2 DX System is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The Aperio AT2 DX System is not use with frozen section, cytology, or non-FFPE hematopathology specimens.

    The Aperio AT2 DX System is composed of the Aperio AT2 DX scanner, the ImageScope DX review application and Display. The Aperio AT2 DX System is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the interpretation of images obtained using the Aperio AT2 DX System.

    Device Description

    The Aperio AT2 DX System is an automated digital slide creation and viewing system. The system is comprised of an Aperio AT2 DX scanner instrument and a Viewing Workstation with a computer and a calibrated monitor executing ImageScope DX viewer software. The system capabilities include digitizing microscope slides at diagnostic resolution, retrieving and displaying digital slides, including support for remote intra-net access over computer networks, providing tools for annotating digital slides, entering data associated with digital slides and displaying the scanned slide images for primary diagnoses by Pathologists.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study details for the Aperio AT2 DX System, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device PerformanceMet?
    Upper bound of the two-sided 95% CI of the difference between overall major discrepancy rates of WSIR diagnoses and MSR diagnoses is
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1