510(k) K260479
- Device
- TheraSphere 360™ Y-90 Management Platform
- Applicant
- Boston Scientific Corporation
- 510(k) number
- K260479
- Product code
- LLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-13
- Date received
- 2026-02-13
- Regulation
- 892.2050
- Classification name
- System, Image Processing, Radiological
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Amy McKinney
- Address
- 300 Boston Scientific Way Marborough MA US 01752 01752
FDA Registration Numbers#
- 3002619337
- 3043532712
- 8043933
- 3015806723
- 3011824442
- 3005860720
- 3005075696
- 3012075008
- 9614209
- 3014398772
- 2183449
- 3004363352
- 1125622
- 1825014
- 3010202439
- 3017058304
- 3004504920
- 3016090213
- 3003895711
- 1226003
- 3009598843
- 3010728558
- 3013497030
- 3017944270
- 9610617
- 1226188
- 3014262693
- 3005172103
- 3016851379
- 9615916
- 3010160527
- 3000219976
- 2952596
- 3008364043
- 3006209933
- 3027408258
- 2126677
- 3008693672
- 3015276088
- 3007362683
- 9613445
- 3004009431
- 3013342228
- 9680825
- 3007697958
- 3025141
- 3017123055
- 3006165530
- 3008596921
- 3024040179
- 3007350723
- 2320618
- 3038187462
- 3003757027
- 3017991646
- 8043836
- 3003781339
- 3030089065
- 3013839079
- 3010377510
- 3009134655
- 3030979155
- 3004016520
- 8030128
- 3027605321
- 3002907620
- 3008548323
- 3009144915
- 2124215
- 3009341091
- 3035371452
- 3005940400
- 3009238175
- 3027329005
- 3033525986
- 3015168097
- 3002579136
- 3010687441
- 8020021
Source Documents#
Other 510(k) Records For Product Code LLZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260116 | CustoMED Viewer | CustoMED , Ltd. | 2026-06-03 |
| K254265 | Helion Viewer Suite | Videomed Srl ( a Baxter Healthcare Corp company) | 2026-05-27 |
| K253831 | CMN Capillary Function with Virtual Expert for MRI, CT and CBCT | Cercare Medical A/S | 2026-05-18 |
| K254013 | SubtleHD-PET (1.x) | Subtle Medical, Inc. | 2026-05-14 |
| K260321 | HipGuide (V 1.0.0.0) | Orthopedic Driven Imaging, LLC | 2026-05-08 |
| K260716 | Neowise | Cefla S.C. | 2026-05-04 |
| K260009 | LungPoint Virtual Bronchoscopic Navigation (VBN) Software | Broncus Medical, Inc. | 2026-04-24 |
| K254237 | CCI PACS VIEWER (PACS-US-001) | CliniComp, Intl. | 2026-04-23 |
| K253029 | RW-1 | Mediott, Inc. | 2026-03-31 |
| K253950 | Avatar Medical Vision | Avatar Medical | 2026-03-30 |
| K252195 | ARTICOR planner | Artiness S.R.L | 2026-03-27 |
| K253111 | Aeka Imaging | Good Methods Global, Inc. | 2026-03-13 |
| K251964 | Mimics Thoracic Planner | Materialise NV | 2026-03-12 |
| K253486 | SKIA-Head (Model: SKIA-ST00) | Skia, Inc. | 2026-02-23 |
| K260205 | AS Software Version Asera | AS Software, LLC | 2026-02-19 |