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
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Amy McKinney
- Address
- 300 Boston Scientific Way Marborough MA US 01752 01752
FDA Registration Numbers
- 3025602618
- 3004957385
- 1528142
- 3026612481
- 3017435704
- 3003895711
- 3033524690
- 3019844085
- 2027062
- 3030977776
- 3014954414
- 3033527282
- 3018133052
- 3011545155
- 3017210169
- 3007137598
- 3011307657
- 1834331
- 3036495186
- 3006260740
- 3032367
- 3031024978
- 3018405359
- 1063008
- 3011411309
- 3004434200
- 3020162557
- 3008487708
- 3042369547
- 9614981
- 3014809646
- 3016090213
- 3030228575
- 3011706018
- 1125622
- 3009293341
- 3007545404
- 2954358
- 3017058304
- 3019878658
- 1045254
- 3023546785
- 3021032044
- 3018733944
- 8010177
- 3006551230
- 3013427569
- 3009048384
- 3011221136
- 3010331645
- 3030228551
- 3014132130
- 3008840981
- 3007734888
- 8043933
- 3033508292
- 3017585294
- 3026309987
- 3007603826
- 9611343
- 3003202425
- 2183449
- 1723170
- 3003370689
- 3011189058
- 3008962159
- 3006621332
- 3038187462
- 2126677
- 3014146081
- 3030089065
- 3013552417
- 3025343020
- 3027329005
- 3021625328
- 3030979155
- 3004537781
- 3013041594
- 3009196021
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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