# K212587: 3D-RD-S

- Pathway: 510(k) (Traditional)
- Applicant: Radiopharmaceutical Imaging and Dosimetry, LLC
- Decided: Feb 22, 2023 after 555 days
- Product code: IYX (Camera, Scintillation (Gamma))
- Device class: 1
- Regulation: 21 CFR 892.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K033960 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163687: Olinda Exm, Hermes Medical Solutions AB (2017) Summary page 4.

## 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 administrated 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/K212587
Methodology: https://510kreport.com/methodology