# K220630: TorchTM Software

- Pathway: 510(k) (Traditional)
- Applicant: Voximetry, Incorporated
- Decided: Nov 28, 2022 after 269 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: 15 generations back to K954874 (1996). 101 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 103 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 4.
- K163687: Olinda Exm, Hermes Medical Solutions AB (2017) Summary page 4.

## Most influential descendants
- K241765: PLANET Onco Dose (3.2) (2025), 0 descendants of its own

## Indications for use
Torch™ software is intended to provide estimates (deterministic) of absorbed radiation dose at the voxel level following internal administration of approved radioactive products. This is dependent on input data regarding biodistribution being supplied to the application. Torch software only allows voxel-based dose calculations. For use with internally administered radioactive products. Torch 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/K220630
Methodology: https://510kreport.com/methodology