# K243919: Voxel Dosimetry (00859873006226)

- Pathway: 510(k) (Traditional)
- Applicant: Hermes Medical Solutions AB
- Decided: Jul 30, 2025 after 222 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K954874 (1996). 101 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 104 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191216: Voxel Dosimetry™ v1.0, Hermes Medical Solutions AB (2019) Summary page 5.

## Most influential descendants
- K262060: 3D-RD-S (2026), 0 descendants of its own
- K253835: Affinity (2026), 0 descendants of its own

## Indications for use
Voxel Dosimetry is intended for patients of any age and gender undergoing radionuclide therapy. Voxel Dosimetry is only intended for calculating dose for FDA approved radiopharmaceuticals. Voxel Dosimetry should not be used to deviate from approved product dosing and administration instructions. Refer to the product's prescribing information for instructions.

Source page: https://510kreport.com/device/K243919
Methodology: https://510kreport.com/methodology