# K262060: 3D-RD-S

- Pathway: 510(k) (Traditional)
- Applicant: Radiopharmaceutical Imaging & Dosimetry, LLC
- Decided: Sep 4, 2026 after 78 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: 16 generations back to K954874 (1996). 102 ancestors in all.
No later device cites it as a predicate yet.
1 of 103 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243919: Voxel Dosimetry (00859873006226), Hermes Medical Solutions AB (2025) Summary page 5.

## Indications for use
3D-RD-S is intended to estimate radiation absorbed dose (and related quantities) to tissues after administration of a radioactive product. For use with internally administered radioactive products, 3D-RD-S should not be used to deviate from product dosing and administration instructions. Refer to the product's prescribing information for instructions.

Source page: https://510kreport.com/device/K262060
Methodology: https://510kreport.com/methodology