uOmnispace is a medical image post-processing software solution that supports viewing, manipulation, annotation, and communication of various medical images from multiple modalities including CT, MRI, PET and DR. It includes AI-based segmentation tools like rib segmentation, and enables remote multi-user access and integration with medical imaging systems. It helps clinicians efficiently analyze and report on diagnostic images.
Intended Use
uOmnispace is a software solution intended to be used for viewing, manipulation, communication and storage of medical images. It allows processing and filming of multimodality DICOM images. It can be used standalone or with other software, intended for use by trained professionals.
Technology
Software-only medical device supporting 2D/3D viewing, annotation, measurement, manual and automatic segmentation (rib extraction algorithm based on machine learning). Supports CT, MRI, PET, DR multimodality images and multi-user remote access through DICOM 3.0 standard.
Performance
Performance evaluation focused on ML-based rib segmentation on chest CT data showed average Dice coefficient of 0.855 exceeding acceptance criteria of 0.8, indicating clinically equivalent performance to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/6/2023
6 months - 2
FDA Approval
7/20/2023
Other devices from Shanghai United Imaging Healthcare Co., Ltd
- uDR 780i2024 • 510K
- uDR 380i Pro2024 • 510K
- uMI Panorama2024 • 510K
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