ART-Plan
TheraPanaceaART-Plan is a medical software tool that helps clinicians plan radiation therapy for cancer patients. It supports image registration and fusion of CT, PET, and MRI scans to better visualize tumor and healthy tissues. It offers automatic, semi-automatic, and manual contouring of organs at risk and lymph nodes, saving time and improving precision in treatment planning. The software is meant for use by trained professionals in clinical settings.
Intended Use
ART-Plan is a software designed to assist the contouring process of the target anatomical regions on 3D-images of cancer patients for whom radiotherapy treatment has been planned.
Technology
ART-Plan comprises two modules: SmartFuse for image registration (rigid and deformable) of multimodal images (CT, PET, MR), and Annotate for manual and automatic contour editing including automatic delineation of organs at risk and healthy lymph nodes. It supports DICOM 3.0 datasets and facilitates visualization, image fusion and segmentation towards radiation therapy planning.
Performance
The device underwent comprehensive performance testing including usability, segmentation performance on various datasets, fusion and registration accuracy per AAPM guidelines and POPI-model, software verification and validation. All tests passed, supporting safety and effectiveness without adverse findings.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/16/2020
4 months - 2
FDA Approval
1/14/2021
Other devices from TheraPanacea
- ART-Plan (v.2.2.0)2024 • 510K
- ART-Plan2023 • 510K
- ART-Plan2023 • 510K
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