RadUnity (Version 1.0.0)
RadUnity Corp.RadUnity (Version 1.0.0) is a software device designed to centralize, manage, standardize, and network CT images using the DICOM protocol. It reformats CT medical images according to user-defined preferences to ensure consistent image formatting, thus supporting qualified radiology professionals in preparing images for interpretation. It is not intended for primary diagnostic review nor for mammographic image interpretation.
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 or mammographic image review or interpretation.
Technology
RadUnity is a stand-alone software device (SaMD) that allows centralized specification, management, standardization, and networking of CT images. It ingests DICOM CT image data and reformats them according to predefined user preferences. The software runs on standard computer hardware and has a web browser-based graphical user interface. RadUnity supports image filtering, multiplanar reformatting (MPR), maximum intensity projection (MIP), and minimum intensity projection (MinIP). It transfers processed images via the DICOM protocol.
Performance
Software verification and validation testing were conducted, confirming that design requirements and user needs were met. Usability validation was performed by board-certified radiologists. RadUnity conforms with DICOM standards and FDA cybersecurity guidance. Performance testing showed RadUnity performs equivalently to predicate devices in safety and effectiveness. No clinical performance data were necessary.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/18/2024
2 months - 2
FDA Approval
11/26/2024
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