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510(k) Data Aggregation

    K Number
    K242810
    Device Name
    RadUnity (Version 1.0.0)
    Manufacturer
    Date Cleared
    2024-11-26

    (69 days)

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

    RadUnity Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    RadUnity receives medical images from CT imaging acquisition devices adhering to the DICOM protocol for image transfer. RadUnity performs image management and digital image processing (centralized specification and reformatting) on the data. The processed images are transferred using the DICOM protocol to other devices supporting this standard protocol. RadUnity is indicated for use by qualified radiology professionals and specialists. RadUnity is not intended for primary diagnostic review. RadUnity is not intended for mammographic image review or interpretation.
    Device Description
    RadUnity is stand-alone software device (SaMD) which allows centralized specification, management, standardization, and networking of CT images. RadUnity's software ingests DICOM CT image data and reformats them according to predefined user preferences. Radunity processes industry standard DICOM imaging studies. Currently, the RadUnity solution only processes computed tomography (CT) images. The data may flow into the system from PACS, a post-processing system, or any DICOM node (e.g., directly from a modality unit). The data is transferred for image processing and standardization. The data is then routed to user defined DICOM destinations and output in DICOM format. RadUnity is fundamentally a workflow management system which performs image processing and standardization which allows the clinical user to view the CT images with consistent formatting. RadUnity provides the user with the ability to duplicate current clinical workflow steps required to generate images for qualified clinician interpretation that may involve automatic or manual steps. The RadUnity solution requires manual user interaction to generate and route images to DICOM destinations for qualified clinician interpretation. The input DICOM images needed for RadUnity are referred to as "source volumes". These source volumes are commonplace in the radiology community today (e.g., lung or bone reconstructions) and contain the needed information to create soft tissue and other thicker slice and lower resolution image volumes.
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