AI Segmentation
Varian Medical Systems, Inc.AI Segmentation by Varian Medical Systems is a cloud-based AI software tool that segments patient anatomical structures from CT scans to assist radiation therapy treatment planning. It automatically delineates organs at risk in regions such as head and neck, thorax, pelvis, and abdomen, helping radiation therapy professionals by streamlining contouring tasks and integrating with treatment planning systems, though clinicians review and approve the results.
Intended Use
AI Segmentation uses CT images to segment patient anatomy for use in radiation therapy treatment planning, covering head and neck, thorax, pelvis, and abdomen.
Technology
AI Segmentation is a cloud-based software that combines deep learning and classical algorithms to automatically segment organs at risk. It provides a web user interface for review and selection of contours, and exports results to the Eclipse Treatment Planning System. It uses static AI algorithms that don't adapt over time and does not include manual contouring tools.
Performance
Software verification and validation testing was conducted according to FDA guidance, demonstrating conformance to functional, usability, and safety requirements. No clinical or animal studies were performed. The device complies with recognized standards including IEC 62304, IEC 62366-1, IEC 62083, and IEC 82304-1.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/25/2020
4 months - 2
FDA Approval
4/19/2021
Other devices from Varian Medical Systems, Inc.
- Gating Reflector Block2024 • 510K
- Vitesse (5.0)2024 • 510K
- Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)2024 • 510K
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