510(k) · Cleared
ClearedIntuition Image
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Jan 21, 2004 as substantially equivalent to K020631 (Brainlab AG, 2002) and 1 other predicate after a 160-day review. Its family tree reaches back 2 generations to 1992. 35 later devices descend from it.
- Decided
- Jan 21, 2004
- Review
- 160 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K920879 (1992). 8 ancestors in all. 35 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK920879 Brainscan Radiosurgery ModuleBrainlab · 1992 · Recalled
- 1 generation backK994413 BrainscanBrainlab AG · 2000 · Recalled
- This deviceK032511 Intuition ImageBrainlab AG · 2004
- Descendant · cites it directly · 34 of its ownK052220 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
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K052220Iplan RT FibertrackingBrainlab AG · 2005 · cites it directly34descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920879 | Brainscan Radiosurgery Module | Brainlab | 1992 | 1 |
| −1 | K994413 | Brainscan | Brainlab AG | 2000 | 1 |
| 0 (this device) | K032511 | Intuition Image | Brainlab AG | 2004 | — |
| +1 | 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 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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 LHN? 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 LHN device
- #1 K260597 Virtue QAscore 15.4 · 12 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 |
|---|---|---|---|
| * | K020631 | IPLANSummary page 1…name: Intuition Image CommorVClassification Name: Planning System/X-ray radiation therapy system Predicate Device: iPlan! (K020631) BrainSCAN (K994413) Device Classification Name: X-ray radiation therapy system Regulatory Class: Class 1I Intended Use: Intui… | 2002 |
| * | K994413 | BrainscanSummary page 1…Intuition Image CommorVClassification Name: Planning System/X-ray radiation therapy system Predicate Device: iPlan! (K020631) BrainSCAN (K994413) Device Classification Name: X-ray radiation therapy system Regulatory Class: Class 1I Intended Use: Intuition Image's indicat… | 2000 |
What descends from it? (35)
See all 352 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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 7.5 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K052220 (Brainlab AG, 2005) has gone furthest, with 34 descendants of its own.
- 4 other devices also cite its predicate K020631.
How does its category compare?
All LHN devicesLHN System, Radiation Therapy, Charged-Particle, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LHN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LHN
190in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LHN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LHN
11in 2025
MAUDE reports naming product code LHN, 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 | 2 | — | 2 | 0 |
| 2008 | 3 | 113 | 2 | 1 |
| 2009 | 5 | 69 | 0 | 5 |
| 2010 | 4 | 96 | 0 | 3 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 3 | 111 | 0 | 1 |
| 2013 | 3 | 70 | 0 | 1 |
| 2014 | 4 | 93 | 2 | 5 |
| 2015 | 3 | 53 | 1 | 2 |
| 2016 | 7 | 120 | 0 | 1 |
| 2017 | 4 | 173 | 5 | 7 |
| 2018 | 3 | 78 | 2 | 8 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 4 | 74 | 1 | 20 |
| 2021 | 0 | — | 1 | 24 |
| 2022 | 2 | — | 2 | 10 |
| 2023 | 2 | — | 1 | 7 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 3 | 190 | 0 | 11 |
| 2026 | 4 | 194 | 0 | — |
What is it indicated for?
Intuition Image'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
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032511: Intuition Image.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032511
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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