# K191216: Voxel Dosimetry™ v1.0

- Pathway: 510(k) (Traditional)
- Applicant: Hermes Medical Solutions AB
- Decided: Oct 17, 2019 after 164 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 14 generations back to K954874 (1996). 100 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 106 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182624: MIM - MRT Dosimetry, Mim Software, Inc. (2018) Summary page 4.
- K163687: Olinda Exm, Hermes Medical Solutions AB (2017) Summary page 4.

## Most influential descendants
- K243919: Voxel Dosimetry (00859873006226) (2025), 2 descendants of its own
- K220630: TorchTM Software (2022), 1 descendant of its own
- K262060: 3D-RD-S (2026), 0 descendants of its own
- K253835: Affinity (2026), 0 descendants of its own
- K241765: PLANET Onco Dose (3.2) (2025), 0 descendants of its own

## Indications for use
The intended use of Voxel Dosimetry™ is to provide estimates (deterministic) of absorbed radiation dose at voxel level as a result of administering one of the supported radionuclides and to provide a dose map. This is dependent on input data regarding bio distribution being supplied to the application. Voxel Dosimetry™ only allows voxel-based dose calculations for patients who have been administered with radioisotopes. Warning! The Voxel Dosimetry™ js only intended for calculating dose for FDA approved radiopharmaceuticals for any clinical purpose, and calculation of unapproved drugs can only be used for research purpose.

Source page: https://510kreport.com/device/K191216
Methodology: https://510kreport.com/methodology