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510(k) Data Aggregation

    K Number
    K252988

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-01-05

    (109 days)

    Product Code
    Regulation Number
    892.5050
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K220583, K220582, K242729, K173636

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

    ChartCheck is intended to assist with the quality assessment of radiotherapy treatment plans and on treatment review.

    Device Description

    The ChartCheck device is software that enables trained radiation oncology personnel to perform quality assessments of treatment plans and treatment chart reviews utilizing plan, treatment, imaging, as well as documentation data obtained from an Oncology Information System database(s).

    ChartCheck contains 3 main components:

    a. An agent service that is configured by the user to monitor an Oncology Information System (OIS) database. The agent watches for new treatment plans, treatment records, documentation, and images. The agent uploads data to a checking service.

    b. A checking service that compares the treatment records to the treatment plan and calculates check states as new records are uploaded from the agent. The checking service processes on-treatment imaging data and interfaces with outside software platforms for dose calculation activities.

    c. A web application accessed via a web browser that contains several components.
    i. Chart checking mode, which allows a medical physicist to review treatment records and check state results, record chart check comments, and mark the chart check as approved.
    ii. An image viewer that allows a medical physicist to review on-treatment imaging, on-treatment dose calculation results, and perform deformable registration editing.
    iii. Settings mode, which allows an administrator to set check state colors, configure settings, define check state templates, set up check alerts, documentation generation, and billing settings.

    AI/ML Overview

    N/A

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