PLANET Onco Dose (3.2)
DOSIsoft SAPLANET Onco Dose (3.2) is a specialized software platform designed for medical professionals in molecular imaging and oncology. It helps manage and analyze various anatomical and functional medical images such as CT, MRI, SPECT, PET, and others. The software supports tumor and normal tissue segmentation, image co-registration, therapy response evaluation, and computes radiation doses at a voxel level for radionuclide-based therapies, improving treatment planning and patient care.
Intended Use
PLANET Onco Dose is a standalone software intended to manage, process, display and analyze anatomical and functional images to assist in medical diagnosis, therapy response assessment, contouring of regions of interest, and internal dosimetry computation for radionuclide based therapies.
Technology
The software platform includes modules for image review, fusion, and registration of multimodal anatomical and functional images. It provides contouring, tumor segmentation, therapy response quantification, and internal dosimetry computation using two dose calculation algorithms (voxel S Value dose kernel convolution and local energy deposition). It supports FDA approved isotopes and allows import/export of DICOM data. Partial volume effect correction and reinforced cybersecurity measures are included.
Performance
PLANET Onco Dose underwent performance, functional, algorithmic testing, risk management assessment, and validation under clinically representative conditions. Verification covered workflows such as SIRT, full SPECT/CT pharmacokinetics, hybrid 2D/3D, and single time point pharmacokinetics for molecular radiotherapy. Results demonstrate safety and effectiveness, with dose algorithms showing consistency with Monte Carlo methods.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/20/2024
8 months - 2
FDA Approval
3/14/2025
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