510(k) · Cleared
Recalled · 2009Brainscan
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 Jul 13, 2000 as substantially equivalent to K920879 (Brainlab, 1992) and 1 other predicate after a 197-day review. Its family tree reaches back 1 generation to 1992. 64 later devices descend from it. It has been recalled once.
- Decided
- Jul 13, 2000
- Review
- 197 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K920879 (1992). 2 ancestors in all. 64 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK920879 Brainscan Radiosurgery ModuleBrainlab · 1992 · Recalled
- This deviceK994413 BrainscanBrainlab AG · 2000
- Descendant · cites it directly · 60 of its ownK053584 Iplan RT DoseBrainlab AG · 2006 · Recalled
- Descendant · cites it directly · 35 of its ownK032511 Intuition ImageBrainlab AG · 2004
- Descendant · 2 generations on · 34 of its ownK052220 Iplan RT FibertrackingBrainlab AG · 2005
- Descendant · 2 generations on · 33 of its ownK080886 Iplan RT ImageBrainlab AG · 2008
- Descendant · cites it directly · 33 of its ownK080888 Modeification to Iplan RT DoseBrainlab AG · 2008 · Recalled
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 64 · See all- K053584Iplan RT DoseBrainlab AG · 2006 · cites it directly60descendants
- K032511Intuition ImageBrainlab AG · 2004 · cites it directly35descendants
- K052220Iplan RT FibertrackingBrainlab AG · 2005 · 2 generations on34descendants
- K080886Iplan RT ImageBrainlab AG · 2008 · 2 generations on33descendants
- K080888Modeification to Iplan RT DoseBrainlab AG · 2008 · cites it directly33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920879 | Brainscan Radiosurgery Module | Brainlab | 1992 | 1 |
| 0 (this device) | K994413 | Brainscan | Brainlab AG | 2000 | — |
| +1 | K053584 | Iplan RT Dose | Brainlab AG | 2006 | 3 |
| +1 | K032511 | Intuition Image | Brainlab AG | 2004 | — |
| +2 | K052220 | Iplan RT Fibertracking | Brainlab AG | 2005 | — |
| +2 | K080886 | Iplan RT Image | Brainlab AG | 2008 | — |
| +1 | K080888 | Modeification to Iplan RT Dose | Brainlab AG | 2008 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 6 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 6 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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? (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 |
|---|---|---|---|
| * | K920879 | Brainscan Radiosurgery ModuleSummary page 1…me: BrainSCAN Current version number: 5.0 Classification name: X-ray radiation therapy system (per 21CFR892.5900) 3. Predicate Devices: BrainSCAN Radiosurgery Module (K920879) BrainSCAN Conformal RT Module (K971367) 4. Device Description BrainSCAN is a software program to generate treatment plans and… | 1992 |
| * | K971367 | Brainscan Conformal RT ModuleSummary page 1….0 Classification name: X-ray radiation therapy system (per 21CFR892.5900) 3. Predicate Devices: BrainSCAN Radiosurgery Module (K920879) BrainSCAN Conformal RT Module (K971367) 4. Device Description BrainSCAN is a software program to generate treatment plans and to simulate the dose defiv- ery for exte… | 1997 |
What descends from it? (64)
See all 643 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 12, 2009 | Not classified | Z-2251-2009 | Other | Failure to conduct important safety checks when using the BrainLab radiotherapy treatment planning software in combination with BrainLab conical collimators could result in unintended radiation outside the conical shaped field, which may… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K053584 (Brainlab AG, 2006) has gone furthest, with 60 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.
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?
BrainSCAN is a stereotactic radiation treatment planning system 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994413 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994413: Brainscan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994413
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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