510(k) · Cleared
ClearedMobius3D (4.1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems · IYE Accelerator, Linear, Medical
Cleared on May 16, 2025 as substantially equivalent to K203669 (Varian Medical Systems, Inc., 2021) after a 122-day review. Its family tree reaches back 14 generations to 1996.
- Decided
- May 16, 2025
- Review
- 122 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K954874 (1996). 79 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 14 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 10 generations between
- 3 generations backK191761 Mobius3DVarian Medical Systems, Inc. · 2019
- 2 generations backK192424 Mobius3DVarian Medical Systems, Inc. · 2019
- 1 generation backK203669 Mobius3DVarian Medical Systems, Inc. · 2021
- This deviceK250099 Mobius3D (4.1)Varian Medical Systems · 2025
Show all 14 generations
- Root · 14 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 13 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 12 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 11 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 10 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 9 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 8 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 7 generations backK062163 MimviewerMimvista Corp. · 2006
- 6 generations backK070248 VelocityaisVelocity Medical Solutions, LLC · 2007
- 5 generations backK081076 Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC · 2008 · Recalled
- 4 generations backK153014 Mobius3DMobius Medical Systems, LP · 2016
- 3 generations backK191761 Mobius3DVarian Medical Systems, Inc. · 2019
- 2 generations backK192424 Mobius3DVarian Medical Systems, Inc. · 2019
- 1 generation backK203669 Mobius3DVarian Medical Systems, Inc. · 2021
- This deviceK250099 Mobius3D (4.1)Varian Medical Systems · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −13 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −12 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −11 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −10 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −9 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −8 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −7 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −6 | K070248 | Velocityais | Velocity Medical Solutions, LLC | 2007 | — |
| −5 | K081076 | Velocityais, Velocity AI, Velocityvx, Velocityrt, V-Response | Velocity Medical Solutions, LLC | 2008 | 1 |
| −4 | K153014 | Mobius3D | Mobius Medical Systems, LP | 2016 | — |
| −3 | K191761 | Mobius3D | Varian Medical Systems, Inc. | 2019 | — |
| −2 | K192424 | Mobius3D | Varian Medical Systems, Inc. | 2019 | — |
| −1 | K203669 | Mobius3D | Varian Medical Systems, Inc. | 2021 | — |
| 0 (this device) | K250099 | Mobius3D (4.1) | Varian Medical Systems | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 9 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 6 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2014 | 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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 |
|---|---|---|---|
| * | K203669 | Mobius3DSummary page 5…ion Name: Accelerator, Linear, Medical Regulation Number: §892.5050 Product Code: IYE III. Predicate Device Mobius3D 4.0 (K203669) There is no change in intended use. IV. Device Description Mobius3D is a software product… | 2021 |
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 29 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 17 of the 79 ancestors have a recall of any class.
- 1 other device also cites its predicate K203669.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
Mobius3D software is used for quality assurance, treatment plan verification, and patient alignment and anatomy analysis in radiation therapy. It calculates radiation dose three dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as…
Read the full statement (122 words)
Mobius3D software is used for quality assurance, treatment plan verification, and patient alignment and anatomy analysis in radiation therapy. It calculates radiation dose three dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Patient alignment and anatomy analysis is based on read-in treatment planning images (such as computed tomography) and read-in daily treatment images (such as registered cone beam computed tomography).
Mobius3D is not a treatment planning system. It is to be used only by trained radiation oncology personnel as a quality assurance tool.
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/K250099 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250099: Mobius3D (4.1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250099
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026