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510(k) Data Aggregation

    K Number
    K241108
    Device Name
    RemedyLogic AI MRI Lumbar Spine Reader
    Manufacturer
    Date Cleared
    2024-10-30

    (191 days)

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

    Remedy Logic Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    RemedyLogic AI MRI Lumbar Spine Reader ("RAI") is an image post-processing and measurement software tool that provides quantitative spine measurements from previously-acquired DICOM lumbar spine Magnetic Resonance (MR) images for users' review, and interpretation. It provides the following functionality to assist users in visualizing, measuring and documenting measurements: · Feature segmentation; · Feature measurement; and · Exportation of measurement results in DICOM Structured Report and a downloadable .docx file for users to review and to use full or partial list of software-generated measurements to prepare their own radiology report. RAI does not produce or recommend any type of medical diagnosis or treatment. Instead, it simply helps users to more easily identify and measure features in lumbar MR images and compile their own reports. The user is responsible for reviewing, verifying, and correcting, if necessary, the software-generated segmentations and measurements, leveraging useful software output and using their medical judgment and discretion to make diagnostic or treatment decisions. The device is intended to be used only by radiologists, neuro- and spine-surgeons in hospitals and other medical institutions. Only T2 MRI images in DICOM format, acquired from lumbar spine exams of patients aged 18 and older, are considered to be valid input. RAI does not support DICOM images of patients that are pregnant, undergo MRI scan with contrast media, or have post-operational complications, scoliosis, tumors, infections, and/or fractures.
    Device Description
    The RemedyLogic AI MRI Lumbar Spine Reader (RAI) is an MR image post-processing and measurement software tool that provides quantitative spine measurements from previously acquired DICOM lumbar spine Magnetic Resonance (MR) images for qualified users' review, analysis, and interpretation. The qualified users (i.e., radiologists, spine- and neuro-surgeons) are physicians qualified to read and interpret spine MRI exams in a manner consistent with American College of Radiology (ACR) recommendations. The RAI analyzes the user-uploaded lumbar spine images and provides the following functionalities to assist qualified users in visualizing images, and measuring images, and generating reports: - Feature segmentation: the software automatically detects the borders of anatomical objects of interest and generates the corresponding contours for these objects. - 0 Feature measurement: the software automatically generates common measurements for segmented objects. - 0 Measurement export: a DICOM Structured Report or a .docx file containing the measurement results can be exported for users to review and to use the full or a partial list of the softwaregenerated measurements to prepare their own radiology reports. The RAI software does not interface directly with any MR scanner or data collection equipment. Rather, a qualified user must upload a previously acquired MR study in DICOM format into the RAI software via their Picture Archiving and Communication System (PACS). The PACS serves as the RAI user interface. After less than two minutes of processing, the RAI software automatically generates and uploads back to PACS the DICOM with segmentations of regions of interest along with corresponding measurements. These measurements are also presented in a DICOM Structured Report and a downloadable .docx file, which is accessible for download from the PACS from PACS system. The user reviews the softwaregenerated measurement list, studies the software-annotated images and/or the original unannotated images when necessary, and reviews other pertinent medical information about the patient. The user can manually segment anatomical objects and mark their own measurements using the DICOM viewer tools. The user can also edit measurements in the downloaded .docx file. The user then writes their own radiology report, incorporating some or all verified or corrected measurements, with diagnosis and/or treatment recommendations. The purpose of the RAI software is to save time by automating tedious, time-consuming, and potentially error-prone manual tasks. The software does not perform any functions that could not be accomplished by a qualified user. The outputs of the software, i.e. feature segmentations and quantitative measurements, are reviewed, analyzed, confirmed or corrected by the user before any such content is included in the user's final report. The RAI consists of a cloud-based machine learning (ML) analytical algorithm deployed on a GPU cloud service and an API to integrate directly with the client's PACS system.
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