Voxel Dosimetry (00859873006226)
Hermes Medical Solutions ABVoxel Dosimetry is a software tool used in nuclear medicine to calculate the absorbed radiation dose distribution within a patient's body at the small voxel level and for specific organs. It uses deep learning based semi-automatic segmentation and non-rigid image registration to analyze images post-radionuclide therapy, providing clinicians with detailed dose mapping to assist in treatment planning and evaluation.
Intended Use
Voxel Dosimetry is a software application for nuclear medicine that calculates a volumetric map of the distribution of absorbed radiation dose on the voxel level for patients administered with radioisotopes.
Technology
Voxel Dosimetry employs deep learning based semi-automatic segmentation for organs and lesions, non-rigid image registration, single time point and organ-based absorbed dose calculations, with GPU accelerated dose calculation using CUDA.
Performance
Software verification and validation followed FDA guidance for device software. Non-clinical performance testing showed algorithm outputs met acceptance criteria compared to manual methods and established standards for segmentation accuracy and dose calculation, including reproducibility tests and computational comparisons between GPU and CPU implementations.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/20/2024
7 months - 2
FDA Approval
7/30/2025
Other devices from Hermes Medical Solutions AB
- Hybrid Viewer (00859873006189)2024 • 510K
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