510(k) · Cleared
ClearedRT Elements (4.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Mar 14, 2023 as substantially equivalent to K203681 (Brainlab AG, 2021) after a 141-day review. Its family tree reaches back 7 generations to 1992. 1 later device descends from it.
- Decided
- Mar 14, 2023
- Review
- 141 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K920879 (1992). 17 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK920879 Brainscan Radiosurgery ModuleBrainlab · 1992 · Recalled
- 6 generations backK994413 BrainscanBrainlab AG · 2000 · Recalled
- 5 generations backK032511 Intuition ImageBrainlab AG · 2004
- 4 generations backK052220 Iplan RT FibertrackingBrainlab AG · 2005
- 3 generations backK080886 Iplan RT ImageBrainlab AG · 2008
- 2 generations backK103246 Iplan RTBrainlab AG · 2011 · Recalled
- 1 generation backK203681 RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial…Brainlab AG · 2021
- This deviceK223279 RT Elements (4.0)Brainlab AG · 2023
- Descendant · cites it directly · 0 of its ownK250440 RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements)…Brainlab AG · 2025
Most influential descendants
Showing 1 of 1 · See all- K250440RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS…Brainlab AG · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K920879 | Brainscan Radiosurgery Module | Brainlab | 1992 | 1 |
| −6 | K994413 | Brainscan | Brainlab AG | 2000 | 1 |
| −5 | K032511 | Intuition Image | Brainlab AG | 2004 | — |
| −4 | K052220 | Iplan RT Fibertracking | Brainlab AG | 2005 | — |
| −3 | K080886 | Iplan RT Image | Brainlab AG | 2008 | — |
| −2 | K103246 | Iplan RT | Brainlab AG | 2011 | 2 |
| −1 | K203681 | RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine… | Brainlab AG | 2021 | — |
| 0 (this device) | K223279 | RT Elements (4.0) | Brainlab AG | 2023 | — |
| +1 | K250440 | RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS… | Brainlab AG | 2025 | — |
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 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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 MUJ? 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 MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K203681 | RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT…Summary page 4…de MUJ Regulation Number 892.5050 Regulatory Class II Panel Radiology Predicate Device K203681 RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250440 | RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS… | 2025 | 0 |
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 31 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 5 of the 17 ancestors have a recall of any class.
- Of its descendants, K250440 (Brainlab AG, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, 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 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
The device is intended for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment and indicated for cranial, head and neck and extracranial lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223279 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223279: RT Elements (4.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223279
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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