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510(k) Data Aggregation

    K Number
    K220929
    Device Name
    Excelsior
    Manufacturer
    Merit CRO, Inc.
    Date Cleared
    2022-10-31

    (214 days)

    Product Code
    NFJ, LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Merit CRO, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ophthalmology The EXCELSIOR Software is intended for use in importing, processing, measurement, and analysis of ophthalmic clinical images as well as in management of clinical data, through a computerized network for use in analysis of images and data obtained in clinical trials. Radiology Excelsior is a software solution intended to be used for viewing, manipulation, annotation, and ysis, and comparison of medical images from multiple imaging modalities and/or multiple time points. The application supports images, functional data such as PET as well as anatomical datasets, such as CT or MR. Excelsior is a software only medical device to be deployed through a cloud-based computerized network via web applications and customized user interfaces for use in the analysis of images and data obtained in clinical trials. Excelsior enables visualization of information that would otherwise have to be visually compared disjointedly. Excelsior provides and workflow automation tools to help the user assess and document the extent of a disease and/or the response to therapy in accordance with user selected standards and assess changes in imaging findings over multiple time-points. Excelsior supports the interpretation and evaluations and follow-up documentation of findings for radiologic oncology imaging and data obtained in clinical trials. The product is intended to be used as a workflow automation tool by trained medical professionals. It is intended to provide image and related information that is interpreted by a trained professional but does not directly generate any diagnosis or potential findings. Note: The medical professional retains the ultimate responsibility for making the pertinent observations based on their standard practices and established practices related to clinical trial outcomes. Excelsior is a complement to these standard procedures. Excelsior is not to be used in mammography.
    Device Description
    The EXCELSIOR software is a cloud-based software that provides a central reading platform integrating remote data collection, quantitative analysis and measurement, storage, and management of ophthalmic and radiological data from DICOM images for clinical trials. The software does not use artificial intelligence or machine learning algorithms.
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