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FDA-cleared K243919

Voxel Dosimetry (00859873006226)

Hermes Medical Solutions AB

Authorized purpose: Voxel Dosimetry 3.1 calculates voxel-level absorbed-dose maps from nuclear-medicine images acquired after administration of FDA-approved therapeutic radiopharmaceuticals and supports single-time-point or time-series workflows.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2025-07-30