510(k) · Cleared
ClearedBrainscan Conformal RT Module
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 Oct 27, 1997 after a 196-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 95 later devices descend from it.
- Decided
- Oct 27, 1997
- Review
- 196 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 0
95 later devices descend from it, 2 citing it directly.
- This deviceK971367 Brainscan Conformal RT ModuleBrainlab AG · 1997
- 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 · cites it directly · 52 of its ownK032762 Xio Radiation Treatment Planning SystemComputerized Medical Systems, Inc. · 2003
- Descendant · 2 generations on · 35 of its ownK032511 Intuition ImageBrainlab AG · 2004
- Descendant · 2 generations on · 34 of its ownK092132 Xio RTP SystemComputerized Medical Systems, Inc. · 2009 · Recalled
Showing 5 of 95 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 95 · See all- K994413BrainscanBrainlab AG · 2000 · cites it directly64descendants
- K053584Iplan RT DoseBrainlab AG · 2006 · 2 generations on60descendants
- K032762Xio Radiation Treatment Planning SystemComputerized Medical Systems, Inc. · 2003 · cites it directly52descendants
- K032511Intuition ImageBrainlab AG · 2004 · 2 generations on35descendants
- K092132Xio RTP SystemComputerized Medical Systems, Inc. · 2009 · 2 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971367 | Brainscan Conformal RT Module | Brainlab AG | 1997 | — |
| +1 | K994413 | Brainscan | Brainlab AG | 2000 | 1 |
| +2 | K053584 | Iplan RT Dose | Brainlab AG | 2006 | 3 |
| +1 | K032762 | Xio Radiation Treatment Planning System | Computerized Medical Systems, Inc. | 2003 | — |
| +2 | K032511 | Intuition Image | Brainlab AG | 2004 | — |
| +2 | K092132 | Xio RTP System | Computerized Medical Systems, Inc. | 2009 | 12 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 7 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 6 | 0 |
| 2022 | 6 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (95)
See all 952 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- 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 | — |
What is it indicated for?
Computer aided planning of static and dynamic conformal radiation therapy treatments.
The BrainSCAN Conformal RT Module is intended to plan radiation therapy treatments of lesions using conformal block collimators that are shaped (i.e. contour molded) to the outline of the lesion in beam’s eye view or using a multileaf collimator. Using shaped collimators helps to deliver radiation exactly to the target volume while sparing surrounding healthy tissue and critical structures from accessing radiation.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971367 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971367: Brainscan Conformal RT Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971367
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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