TheraSphere 360 Y-90 Management Platform
FDA 510(k) K260479 · Boston Scientific Corporation
510(k) numberK260479
Submission
- Device name
- TheraSphere 360 Y-90 Management Platform
- Applicant
- Boston Scientific Corporation
Marborough, MA, US - Received
- February 13, 2026
- Decision date
- March 13, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K260500 | ResolutionMDLLZ · Traditional | ResolutionMD, Inc. | 07/21/2026SE |
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Questions and answers
When was TheraSphere 360 Y-90 Management Platform cleared by the FDA?
TheraSphere 360 Y-90 Management Platform (K260479) received a 510(k) decision of Substantially Equivalent on March 13, 2026, 28 days after the submission was received.
What is the product code of K260479?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.