TheraSphere 360™ Y-90 Management Platform
FDA 510(k) clearance K260479 · decided 2026-03-13
Clearance details
- K-number
- K260479
- Device name
- TheraSphere 360™ Y-90 Management Platform
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2026-02-13
- Decision date
- 2026-03-13
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Marborough, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Boston Scientific Corporation
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RadioViewAI (K260936) | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-07-31 |
| Cleerly LABS (K260588) | Cleerly, Inc. | 2026-07-29 |
| TheraSphere 360™ Y-90 Management Platform (K262462) | Boston Scientific Corporation | 2026-07-24 |
| ImageGrid StreamVue (K262143) | Candelis, Inc. | 2026-07-23 |
| ResolutionMD (K260500) | ResolutionMD, Inc. | 2026-07-21 |
| Avara Viewer (K262120) | Avara Software | 2026-07-10 |
| 3D-Anywhere (K253899) | Provect.AI | 2026-07-09 |
| INDIRA CLOUD VIEWER (K261465) | INDIGO TECHNOLOGIES | 2026-07-06 |
| MeVis AVM Contour (K260576) | MeVis Medical Solutions AG | 2026-06-30 |
| MiPACS V5 (1.0.0) (K260231) | Apryse Software Corp | 2026-06-25 |
| Perfusion Measurement Platform v1 (K253421) | Quantified Imaging Limited | 2026-06-22 |
| 2D Hip Planning Software (K261352) | One Ortho | 2026-06-08 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Rad recall (Z-2771-2026) | Boston Scientific Corporation | 2026-07-22 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Axonics Sacral Neuromodulation System (P190006/S101) | Boston Scientific Corporation | 2025-12-19 |
| Axonics Sacral Neuromodulation System (P180046/S101) | Boston Scientific Corporation | 2025-12-19 |
| SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S110) | Boston Scientific Corporation | 2025-10-29 |
| Innova Vascular Self-Expanding Stent System (P140028/S084) | Boston Scientific Corporation | 2025-10-24 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S039) | Boston Scientific Corporation | 2025-10-24 |
| AGENT Paclitaxel-Coated Balloon Catheter (P230035/S007) | Boston Scientific Corporation | 2025-10-24 |
| ENROUTE® Transcarotid Stent System (P140026/S032) | Boston Scientific Corporation | 2025-10-23 |
| A209 SICD Gen 2,A219 SICD MRI (P110042/S206) | Boston Scientific Corporation | 2025-10-22 |