510(k) · Cleared
ClearedIplan RT Fibertracking
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · IYE Accelerator, Linear, Medical
Cleared on Sep 30, 2005 as substantially equivalent to K041703 (Brainlab AG, 2004) and 1 other predicate after a 46-day review. Its family tree reaches back 3 generations to 1992. 34 later devices descend from it.
- Decided
- Sep 30, 2005
- Review
- 46 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K920879 (1992). 10 ancestors in all. 34 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK920879 Brainscan Radiosurgery ModuleBrainlab · 1992 · Recalled
- 2 generations backK994413 BrainscanBrainlab AG · 2000 · Recalled
- 1 generation backK032511 Intuition ImageBrainlab AG · 2004
- This deviceK052220 Iplan RT FibertrackingBrainlab AG · 2005
- Descendant · cites it directly · 33 of its ownK080886 Iplan RT ImageBrainlab AG · 2008
- Descendant · 2 generations on · 32 of its ownK103246 Iplan RTBrainlab AG · 2011 · Recalled
- Descendant · 3 generations on · 22 of its ownK120387 RaystationRaysearch Laboratories AB · 2012 · Recalled
- Descendant · 4 generations on · 21 of its ownK130617 RaystationRaysearch Laboratories AB · 2013 · Recalled
- Descendant · 5 generations on · 19 of its ownK140187 Ray StationRaysearch Laboratories AB · 2014 · Recalled
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K080886Iplan RT ImageBrainlab AG · 2008 · cites it directly33descendants
- K103246Iplan RTBrainlab AG · 2011 · 2 generations on32descendants
- K120387RaystationRaysearch Laboratories AB · 2012 · 3 generations on22descendants
- K130617RaystationRaysearch Laboratories AB · 2013 · 4 generations on21descendants
- K140187Ray StationRaysearch Laboratories AB · 2014 · 5 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K920879 | Brainscan Radiosurgery Module | Brainlab | 1992 | 1 |
| −2 | K994413 | Brainscan | Brainlab AG | 2000 | 1 |
| −1 | K032511 | Intuition Image | Brainlab AG | 2004 | — |
| 0 (this device) | K052220 | Iplan RT Fibertracking | Brainlab AG | 2005 | — |
| +1 | K080886 | Iplan RT Image | Brainlab AG | 2008 | — |
| +2 | K103246 | Iplan RT | Brainlab AG | 2011 | 2 |
| +3 | K120387 | Raystation | Raysearch Laboratories AB | 2012 | 6 |
| +4 | K130617 | Raystation | Raysearch Laboratories AB | 2013 | 6 |
| +5 | K140187 | Ray Station | Raysearch Laboratories AB | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 5 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K041703 | IPLAN!Summary page 1…T FiberTracking Common/Classification Name: Planning System / Medical charged-particle radiation therapy system Predicate Device: iPlan! FiberTracking (K041703). Intuition Image (K032511). Device Classification Name: Medical charged-particle radiation therapy system Regulatory Class: Cla… | 2004 |
| * | K032511 | Intuition ImageSummary page 1…sification Name: Planning System / Medical charged-particle radiation therapy system Predicate Device: iPlan! FiberTracking (K041703). Intuition Image (K032511). Device Classification Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Indications For Use:… | 2004 |
What descends from it? (34)
See all 341 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080886 | Iplan RT Image | 2008 | 33 |
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 13 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K080886 (Brainlab AG, 2008) has gone furthest, with 33 descendants of its own.
- 1 other device also cites its predicate K041703.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
iPlan RT FiberTracking's indications for use is to prepare and present patient and image data based on CT, MR, Angiographic and other imaging sources including - image preparation - image localization - image fusion - image segmentation - isocenter handling - plan review and approval - fiber tracking where the result is used for stereotactic radiation treatment planning that is intended for use in stereotactic, conformal, computer planned, LINAC based…
Read the full statement (164 words)
iPlan RT FiberTracking's indications for use is to prepare and present patient and image data based on CT, MR, Angiographic and other imaging sources including
- image preparation
- image localization
- image fusion
- image segmentation
- isocenter handling
- plan review and approval
- fiber tracking
where the result is used for stereotactic radiation treatment planning that is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck and extracranial lesions.
Fiber Tracking:
iPlan RT FiberTracking's indication for use is to prepare and present patient and image data based on MRI scanned with diffusion-weighted sequences. These diffusion images are used for the calculation and display of fiber bundles in a selected region of interest. The created treatment plans of iPlan RT FiberTracking can be used with other iPlan treatment plans and other BrainLAB medical devices such as BrainSCAN, iPan RT Image, and iPlan RT Dose where this medical device is used for radiotherapy treatment planning.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052220 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052220: Iplan RT Fibertracking.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052220
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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