- uOmnispace includes 2D and 3D viewing, annotation, and segmentation tools, enhanced by machine learning, for comprehensive imaging and reporting.
- The software supports DICOM images and is compatible with various imaging modalities like CT, MRI, and PET.
- uOmnispace is not intended to display digital mammography images for diagnosis in the U.S.
uOmnispace
uOmnispace is developed by Shanghai United Imaging Healthcare Co., Ltd.. It is a comprehensive medical imaging software solution designed for medical professionals. The software is highly adaptable and can be used as a stand-alone device or integrated with multiple cleared and unmodified software options. It received 510(k) Premarket Notification on July 20, 2023.
uOmnispace is medical imaging software designed for physicians and trained medical technicians. It features 2D and 3D viewing, annotation and measurement tools, manual and automatic segmentation tools, and comprehensive film and reports features. It also offers a rib extraction algorithm using machine learning technology.
uOmnispace supports DICOM images and is compatible with various imaging modalities like CT, MRI, and PET. It’s a software-only medical device and can be used with standard off-the-shelf PCs that meet certain minimum specifications. It allows multiple users to access clinical applications on a network remotely. The system communicates effectively with various imaging and hospital information systems through the DICOM3.0 standard.
However, it is important to note that this software is not intended to display digital mammography images for diagnosis in the U.S.
Reference
K230039 uOmnispace 510(k) Premarket Notification.” n.d. Accessed December 14, 2023. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230039
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