# K252547: TheraSphere 360™ Y-90 Management Platform

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Oct 28, 2025 after 77 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K954874 (1996). 63 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182016: Simplicit90Y, Mirada Medical, Ltd. (2018) Summary page 5.

## Most influential descendants
- K260479: TheraSphere 360™ Y-90 Management Platform (2026), 1 descendant of its own
- K262462: TheraSphere 360™ Y-90 Management Platform (2026), 0 descendants of its own

## Recalls of this device
- Jun 19, 2026 · Class II · Z-2771-2026: Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recal

## 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 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 Microspheres dose vial selection. Additionally, the TheraSphere 360 Platform includes optional post-treatment analysis functionalities to be used following treatment with TheraSphere Microspheres. For post-TheraSphere 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 Microspheres.

Source page: https://510kreport.com/device/K252547
Methodology: https://510kreport.com/methodology