OncoStudio (OS-01)
OncoSoft. Co., Ltd.OncoStudio (OS-01) is a software tool that uses deep learning to automatically outline organs at risk in CT scans. This helps clinicians and radiation oncologists efficiently generate contouring for treatment planning by providing initial contours that can be reviewed and confirmed. The software supports multiple anatomic regions including head & neck, thorax, abdomen, and pelvis, and outputs results in DICOM-RT format compatible with radiation therapy systems.
Intended Use
OncoStudio provides deep-learning-based automatic contouring to organs at risk in DICOM-RT format from CT images for use in radiation oncology treatment planning or other professions needing segmented organ masks.
Technology
Standalone software that performs deep-learning-based automatic contouring on CT images, generates DICOM-RT formatted structure sets, allows manual contouring, and manages medical images including receiving, transmitting, storing, and displaying DICOM objects.
Performance
Performance evaluation was conducted on a separate test set of 310 CT images from multiple international centers with ground truth annotations by experienced radiation oncologists. The dataset included diverse ethnicities and CT manufacturers. The software showed generalizable segmentation results without performance differences by ethnicity.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/26/2024
5 months - 2
FDA Approval
2/24/2025
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