Voxel Dosimetry (00859873006226)

Voxel Dosimetry is a software application for nuclear medicine that calculates volumetric maps of absorbed radiation dose distribution at the voxel level for patients undergoing radionuclide therapy. It performs organ-level dose calculations for kidneys, lungs, liver, and spleen using semi-automatic segmentation, displays results overlaid on imaging for user review and manual correction, and stores results for future analysis.

Voxel Dosimetry version 3.1 adds several new functionalities to version 1.0: non-rigid registration for fine-tuning alignment, deep learning-based semi-automatic organ segmentation, lesion segmentation capability, single time-point dose calculation processing, organ-based dose calculation, and GPU-accelerated dose calculation using CUDA. The core absorbed dose calculation at voxel level, indications for use, and use environment remain unchanged from the predicate.

Not stated in this summary.

Substantial equivalence is established because the subject device maintains the same fundamental design, principles of operation, and primary function as the predicate device—voxel-level absorbed dose calculation for radionuclide therapy. Although new features were added (registration, segmentation, GPU implementation), non-clinical performance testing demonstrates all new algorithms meet pre-set acceptance criteria using published statistical methods or comparison with state-of-the-art devices. Software verification and validation testing confirms the device performs as intended. There is no change in overall safety and effectiveness compared to the predicate.