DV. Target
Deepvoxel INCDV.Target is a software product that uses machine learning algorithms to automatically delineate organs-at-risk on CT images. It supports radiation therapy planning by generating organ contours that clinicians can review and edit in a treatment planning system. The software operates on a server and integrates with clinical workflows through DICOM image routing.
Intended Use
Software application for automatic delineation of organs-at-risk on CT images to assist radiation therapy treatment planning.
Technology
Standalone software processing DICOM CT and RTSTRUCT images, using machine learning algorithms for auto-contouring. Operates on Windows or Ubuntu servers with administration interface for workflow management and routing. Does not include image visualization, relying on external TPS software for review/editing of contours.
Performance
Performance evaluated through three comparative studies using independent public and clinical datasets. Metrics showed DV.Target is non-inferior to predicate and reference devices in auto-contouring accuracy across 49 organs-at-risk. Statistical analyses confirmed good agreement and performance equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/29/2020
6 months - 2
FDA Approval
4/2/2021
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