# K262462: TheraSphere 360™ Y-90 Management Platform

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Jul 24, 2026 after 7 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). 65 ancestors in all.
No later device cites it as a predicate yet.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K260479: TheraSphere 360™ Y-90 Management Platform, Boston Scientific Corporation (2026) Summary page 5.

## Indications for use
The TheraSphere 360™ Y-90 Management Platform includes Treatment Planning and Activity Calculation functionalities as optional interactive tools intended for calculating the activity of TheraSphere Y-90 Microspheres required at treatment time based upon the desired dose, lung shunt fraction, anticipated residual waste, and liver mass. The Treatment Planning and Activity Calculation functionalities include features to aid in TheraSphere Y-90 Microspheres dose vial selection. Additionally, the TheraSphere 360 Platform includes optional post-treatment analysis functionalities to be used following treatment with TheraSphere Y-90 Microspheres. For post-TheraSphere Y-90 Microspheres treatment, the TheraSphere 360 Platform should only be used for the retrospective determination of dose and should not be used to prospectively calculate dose or for pre-treatment planning when there is a need for retreatment using TheraSphere Y-90 Microspheres.

Source page: https://510kreport.com/device/K262462
Methodology: https://510kreport.com/methodology