510(k) · Cleared
ClearedRT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review
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 Apr 9, 2021 as substantially equivalent to K103246 (Brainlab AG, 2011) after a 113-day review. Its family tree reaches back 6 generations to 1992. 2 later devices descend from it.
- Decided
- Apr 9, 2021
- Review
- 113 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K920879 (1992). 16 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK920879 Brainscan Radiosurgery ModuleBrainlab · 1992 · Recalled
- 5 generations backK994413 BrainscanBrainlab AG · 2000 · Recalled
- 4 generations backK032511 Intuition ImageBrainlab AG · 2004
- 3 generations backK052220 Iplan RT FibertrackingBrainlab AG · 2005
- 2 generations backK080886 Iplan RT ImageBrainlab AG · 2008
- 1 generation backK103246 Iplan RTBrainlab AG · 2011 · Recalled
- This deviceK203681 RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial…Brainlab AG · 2021
- Descendant · cites it directly · 1 of its ownK223279 RT Elements (4.0)Brainlab AG · 2023
- Descendant · 2 generations on · 0 of its ownK250440 RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements)…Brainlab AG · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K920879 | Brainscan Radiosurgery Module | Brainlab | 1992 | 1 |
| −5 | K994413 | Brainscan | Brainlab AG | 2000 | 1 |
| −4 | K032511 | Intuition Image | Brainlab AG | 2004 | — |
| −3 | K052220 | Iplan RT Fibertracking | Brainlab AG | 2005 | — |
| −2 | K080886 | Iplan RT Image | Brainlab AG | 2008 | — |
| −1 | K103246 | Iplan RT | Brainlab AG | 2011 | 2 |
| 0 (this device) | K203681 | RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine… | Brainlab AG | 2021 | — |
| +1 | K223279 | RT Elements (4.0) | Brainlab AG | 2023 | — |
| +2 | 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 |
|---|---|---|
| 2023 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K103246 | Iplan RTSummary page 4…MUJ Regulation Number 892.5050 Regulatory Class II Panel Radiology Predicate Device(s) iPlan RT K103246 Contact Information Primary Contact… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223279 | RT Elements (4.0) | 2023 | 1 |
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 29 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 5 of the 16 ancestors have a recall of any class.
- Of its descendants, K223279 (Brainlab AG, 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K103246.
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. 2021, 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 RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck and extracranial lesions. The Multiple Brain Mets SRS application as one RT Element provides optimized planning and display for cranial multi-metastases radiation treatment planning. The Cranial SRS application as one RT Element provides optimized planning and display for cranial…
Read the full statement (169 words)
The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck and extracranial lesions.
The Multiple Brain Mets SRS application as one RT Element provides optimized planning and display for cranial multi-metastases radiation treatment planning.
The Cranial SRS application as one RT Element provides optimized planning and display for cranial radiation treatment planning.
The Spine SRS application as one RT Element provides optimized planning and display for single spine metastases.
The Cranial SRS w/ Cones application as one RT Element provides planning and display for functional diseases (e.g. trigeminal neuralgia) or cranial lesion radiation treatment.
The RT QA application as one RT Element contains features for patient specific quality assurance. Use RT QA to recalculate patient treatment plans on a phantom to verify that the patient treatment plan fulfills the planning requirements.
The Dose Review application as one RT Element contains features for review of isodose lines, review of DVHs, dose comparison and dose summation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203681: RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203681
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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