# K202392: SIR-Spheres Microspheres Activity Calculator (SMAC)

- Pathway: 510(k) (Traditional)
- Applicant: Sirtex Medical US Holdings, Inc.
- Decided: Oct 23, 2020 after 63 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- 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 K010641 (2001). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181468: Hybrid3D, Hermes Medical Solutions AB (2018) Summary page 4.

## Indications for use
The SIR-Spheres® Microspheres Activity Calculator (SMAC) is intended as a tool to assist with developing personalized dose activity calculations, based on relevant patient data, for patients undergoing selective internal radiation therapy (SIRT) with SIR-Spheres Y-90 resin microspheres. Using the BSA formula, the SMAC automatically performs calculations that are typically done manually by a physicist and/or licensed healthcare practitioner. The algorithms used have been established and documented in scientific literature.

Source page: https://510kreport.com/device/K202392
Methodology: https://510kreport.com/methodology