510(k) · Cleared
ClearedTheraSphere 360™ Y-90 Management Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · LLZ System, Image Processing, Radiological
Cleared on Jul 24, 2026 as substantially equivalent to K260479 (Boston Scientific Corporation, 2026) after a 7-day review. Its family tree reaches back 15 generations to 1996.
- Decided
- Jul 24, 2026
- Review
- 7 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K954874 (1996). 65 ancestors in all, the oldest K885054 (1989). No later device cites it as a predicate yet.
- Root · 15 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 11 generations between
- 3 generations backK182016 Simplicit90YMirada Medical, Ltd. · 2018
- 2 generations backK252547 TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation · 2025 · Recalled
- 1 generation backK260479 TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation · 2026 · Recalled
- This deviceK262462 TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation · 2026
Show all 15 generations
- Root · 15 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 14 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 13 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 12 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 11 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 10 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 9 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 8 generations backK062163 MimviewerMimvista Corp. · 2006
- 7 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 6 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 5 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 4 generations backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- 3 generations backK182016 Simplicit90YMirada Medical, Ltd. · 2018
- 2 generations backK252547 TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation · 2025 · Recalled
- 1 generation backK260479 TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation · 2026 · Recalled
- This deviceK262462 TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −14 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −13 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −12 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −11 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −10 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −9 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −8 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −7 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −6 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −5 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| −4 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| −3 | K182016 | Simplicit90Y | Mirada Medical, Ltd. | 2018 | — |
| −2 | K252547 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | 2025 | 1 |
| −1 | K260479 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | 2026 | 1 |
| 0 (this device) | K262462 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K260479 | TheraSphere 360™ Y-90 Management PlatformSummary page 5…el: Radiology Predicate Devices / TheraSphere 360™ Y-90 Management Platform Reference 510(k): (K260479) Date of Preparation: July 17, 2026 Device Description: The TheraSphere 360 Y-90 Management Platform… | 2026 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 15 of the 65 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The TheraSphere 360™ Y-90 Management Platform includes Treatment Planning and Activity Calculation functionalities as optional interactive tools intended for calculating the activity of TheraSphere Y-90 Microspheres required at treatment time based upon the desired dose, lung shunt fraction, anticipated residual waste, and liver mass. The Treatment Planning and Activity Calculation functionalities include features to aid in TheraSphere Y-90 Microspheres…
Read the full statement (124 words)
The TheraSphere 360™ Y-90 Management Platform includes Treatment Planning and Activity Calculation functionalities as optional interactive tools intended for calculating the activity of TheraSphere Y-90 Microspheres required at treatment time based upon the desired dose, lung shunt fraction, anticipated residual waste, and liver mass.
The Treatment Planning and Activity Calculation functionalities include features to aid in TheraSphere Y-90 Microspheres dose vial selection.
Additionally, the TheraSphere 360 Platform includes optional post-treatment analysis functionalities to be used following treatment with TheraSphere Y-90 Microspheres. For post-TheraSphere Y-90 Microspheres treatment, the TheraSphere 360 Platform should only be used for the retrospective determination of dose and should not be used to prospectively calculate dose or for pre-treatment planning when there is a need for retreatment using TheraSphere Y-90 Microspheres.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K262462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262462: TheraSphere 360™ Y-90 Management Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262462
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026