FDA 510(k) ClearanceLLZ
TheraSphere 360™ Y-90 Management Platform
FDA 510(k) K262462 · Boston Scientific Corporation
- 510(k) number
- K262462
- Device name
- TheraSphere 360™ Y-90 Management Platform
- Applicant
- Boston Scientific Corporation
- Product code
- LLZ
- Decision
- Substantially Equivalent
- Decision date
- Device class
- Class 2
- Regulation number
- 892.2050
- Advisory committee
- RA
- Medical specialty
- Radiology
Candidate predicate devices
Other devices cleared under product code LLZ form a screening cohort, not a predicate determination. Compare intended use, technological characteristics, performance evidence, labeling, and current legal-marketing status before selecting a predicate.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261500 | KBA3D (v2.4.0) | S.M.A.I.O | |
| K262449 | AdvaView | ADVAHEALTH SOLUTIONS, LLC | |
| K261916 | NeuroQuant PET | Cortechs Labs, Inc. | |
| K260936 | RadioViewAI | Neurocareai, Inc. (Dba Savelife.Ai) | |
| K260588 | Cleerly LABS | Cleerly, Inc. | |
| K262143 | ImageGrid StreamVue | Candelis, Inc. | |
| K260500 | ResolutionMD | ResolutionMD, Inc. | |
| K262120 | Avara Viewer | Avara Software | |
| K253899 | 3D-Anywhere | Provect.AI | |
| K261465 | INDIRA CLOUD VIEWER | INDIGO TECHNOLOGIES | |
| K260576 | MeVis AVM Contour | MeVis Medical Solutions AG |
Building a 510(k) around this device type?
Assyro turns predicate research into a substantial-equivalence comparison and an eSTAR-ready 510(k) workflow — so predicate strategy, testing evidence, and labeling stay aligned before FDA review.