510(k) · Cleared
Recalled · 2009Brainscan Radiosurgery Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab · IYE Accelerator, Linear, Medical
Cleared on Dec 29, 1992 after a 307-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 65 later devices descend from it. It has been recalled once.
- Decided
- Dec 29, 1992
- Review
- 307 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 1
- Predicates
- 0
65 later devices descend from it, 1 citing it directly.
- This deviceK920879 Brainscan Radiosurgery ModuleBrainlab · 1992
- Descendant · cites it directly · 64 of its ownK994413 BrainscanBrainlab AG · 2000 · Recalled
- Descendant · 2 generations on · 60 of its ownK053584 Iplan RT DoseBrainlab AG · 2006 · Recalled
- Descendant · 2 generations on · 35 of its ownK032511 Intuition ImageBrainlab AG · 2004
- Descendant · 3 generations on · 34 of its ownK052220 Iplan RT FibertrackingBrainlab AG · 2005
- Descendant · 3 generations on · 33 of its ownK080886 Iplan RT ImageBrainlab AG · 2008
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K994413BrainscanBrainlab AG · 2000 · cites it directly64descendants
- K053584Iplan RT DoseBrainlab AG · 2006 · 2 generations on60descendants
- K032511Intuition ImageBrainlab AG · 2004 · 2 generations on35descendants
- K052220Iplan RT FibertrackingBrainlab AG · 2005 · 3 generations on34descendants
- K080886Iplan RT ImageBrainlab AG · 2008 · 3 generations on33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K920879 | Brainscan Radiosurgery Module | Brainlab | 1992 | — |
| +1 | K994413 | Brainscan | Brainlab AG | 2000 | 1 |
| +2 | K053584 | Iplan RT Dose | Brainlab AG | 2006 | 3 |
| +2 | K032511 | Intuition Image | Brainlab AG | 2004 | — |
| +3 | K052220 | Iplan RT Fibertracking | Brainlab AG | 2005 | — |
| +3 | K080886 | Iplan RT Image | Brainlab AG | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 6 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 6 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (65)
See all 651 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K994413 | Brainscan | 2000 | 64 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 12, 2009 | Not classified | Z-2251-2009 | Other | Failure to conduct important safety checks when using the BrainLab radiotherapy treatment planning software in combination with BrainLab conical collimators could result in unintended radiation outside the conical shaped field, which may… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K994413 (Brainlab AG, 2000) has gone furthest, with 64 descendants of its own.
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 | — |
https://510kreport.com/device/K920879 · printed Nov 6, 2026
Cite this page
510(k) Report. “K920879: Brainscan Radiosurgery Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920879
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026