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510(k) Data Aggregation

    K Number
    K250968
    Device Name
    PathPresenter Clinical Viewer
    Manufacturer
    PathPresenter Corporation
    Date Cleared
    2025-06-20

    (81 days)

    Product Code
    N/A
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Pathology (PA)
    Reference & Predicate Devices
    K233027
    Why did this record match?
    Device Name :

    PathPresenter Clinical Viewer

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

    For In Vitro Diagnostic Use

    The PathPresenter Clinical Viewer is a software intended for viewing and managing whole slide images of scanned glass sides derived from formalin fixed paraffin embedded (FFPE) tissue. It is an aid to pathologists to review and render a diagnosis using the digital images for the purposes of primary diagnosis. PathPresenter Clinical is not intended for use with frozen sections, cytology specimens, or non-FFPE specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using PathPresenter Clinical software. PathPresenter Clinical Viewer is intended for use with Hamamatsu NanoZoomer S360MD Slide scanner NDPI image formats viewed on the Barco NV MDPC-8127 display device.

    Device Description

    The PathPresenter Clinical Viewer (version V1.0.1) is a web-based software application designed for viewing and managing whole slide images generated from scanned glass slides of formalin-fixed, paraffin-embedded (FFPE) surgical pathology tissue. It serves as a diagnostic aid, enabling pathologists to review digital images and render a primary pathology diagnosis. Functions of the viewer include zooming and panning the image, annotating the image, measuring distances and areas in the image and retrieving multiple images from the slide tray including prior cases and deprecated slides.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the PathPresenter Clinical Viewer based on the provided FDA 510(k) clearance letter:

    Acceptance Criteria and Device Performance for PathPresenter Clinical Viewer

    1. Table of Acceptance Criteria and Reported Device Performance

    TestAcceptance CriteriaReported Device Performance
    Pixelwise ComparisonThe 95th percentile of the pixel-wise color difference in any image pair is less than 3 CIEDE2000 (
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