510(k) · Cleared
ClearedIplan RT 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 Jun 24, 2008 as substantially equivalent to K032511 (Brainlab AG, 2004) and 2 other predicates after an 85-day review. Its family tree reaches back 4 generations to 1992. 33 later devices descend from it.
- Decided
- Jun 24, 2008
- Review
- 85 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K920879 (1992). 12 ancestors in all. 33 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK920879 Brainscan Radiosurgery ModuleBrainlab · 1992 · Recalled
- 3 generations backK994413 BrainscanBrainlab AG · 2000 · Recalled
- 2 generations backK032511 Intuition ImageBrainlab AG · 2004
- 1 generation backK052220 Iplan RT FibertrackingBrainlab AG · 2005
- This deviceK080886 Iplan RT ImageBrainlab AG · 2008
- Descendant · cites it directly · 32 of its ownK103246 Iplan RTBrainlab AG · 2011 · Recalled
- Descendant · 2 generations on · 22 of its ownK120387 RaystationRaysearch Laboratories AB · 2012 · Recalled
- Descendant · 3 generations on · 21 of its ownK130617 RaystationRaysearch Laboratories AB · 2013 · Recalled
- Descendant · 4 generations on · 19 of its ownK140187 Ray StationRaysearch Laboratories AB · 2014 · Recalled
- Descendant · 5 generations on · 17 of its ownK141860 RaystationRaysearch Laboratories AB · 2014 · Recalled
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K103246Iplan RTBrainlab AG · 2011 · cites it directly32descendants
- K120387RaystationRaysearch Laboratories AB · 2012 · 2 generations on22descendants
- K130617RaystationRaysearch Laboratories AB · 2013 · 3 generations on21descendants
- K140187Ray StationRaysearch Laboratories AB · 2014 · 4 generations on19descendants
- K141860RaystationRaysearch Laboratories AB · 2014 · 5 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K920879 | Brainscan Radiosurgery Module | Brainlab | 1992 | 1 |
| −3 | K994413 | Brainscan | Brainlab AG | 2000 | 1 |
| −2 | K032511 | Intuition Image | Brainlab AG | 2004 | — |
| −1 | K052220 | Iplan RT Fibertracking | Brainlab AG | 2005 | — |
| 0 (this device) | K080886 | Iplan RT Image | Brainlab AG | 2008 | — |
| +1 | K103246 | Iplan RT | Brainlab AG | 2011 | 2 |
| +2 | K120387 | Raystation | Raysearch Laboratories AB | 2012 | 6 |
| +3 | K130617 | Raystation | Raysearch Laboratories AB | 2013 | 6 |
| +4 | K140187 | Ray Station | Raysearch Laboratories AB | 2014 | 1 |
| +5 | K141860 | Raystation | Raysearch Laboratories AB | 2014 | 5 |
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 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K032511 | Intuition ImageSummary page 1…/Classification Name: Planning System / Medical charged-particle radiation therapy system Predicate Device: Intuition Image (K03251 1) iPlan RT FiberTracking (K052220) iPlan BOLD MRI (K053127) Device Classification Name: Medical charged-particle radiation thera… | 2004 |
| * | K052220 | Iplan RT FibertrackingSummary page 1…ning System / Medical charged-particle radiation therapy system Predicate Device: Intuition Image (K03251 1) iPlan RT FiberTracking (K052220) iPlan BOLD MRI (K053127) Device Classification Name: Medical charged-particle radiation therapy system Regulatory Class: Class… | 2005 |
| * | K053127 | IPLANSummary page 1…rged-particle radiation therapy system Predicate Device: Intuition Image (K03251 1) iPlan RT FiberTracking (K052220) iPlan BOLD MRI (K053127) Device Classification Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Intended Use: iPlan… | 2006 |
What descends from it? (33)
See all 331 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103246 | Iplan RT | 2011 | 32 |
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 16 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K103246 (Brainlab AG, 2011) has gone furthest, with 32 descendants of its own.
- 1 other device also cites its predicate K032511.
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. 2008, this device’s year, is highlighted.
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?
iPlan RT Image's indications for use is to prepare and present patient and image data based on CT, MR, Angiographic, PET to include standardized uptake values (SUV) 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/K080886 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080886: Iplan RT Image.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080886
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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