510(k) · Cleared
Recalled · Class II · 2014Iplan RT Dose
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 12, 2006 as substantially equivalent to K994413 (Brainlab AG, 2000) after a 201-day review. Its family tree reaches back 2 generations to 1992. 60 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 12, 2006
- Review
- 201 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K920879 (1992). 3 ancestors in all. 60 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 deviceK053584 Iplan RT DoseBrainlab AG · 2006
- Descendant · cites it directly · 33 of its ownK080888 Modeification to Iplan RT DoseBrainlab AG · 2008 · Recalled
- Descendant · 2 generations on · 32 of its ownK103246 Iplan RTBrainlab AG · 2011 · Recalled
- Descendant · cites it directly · 29 of its ownK080799 Atlas-Based AutosegmentationComputerized Medical Systems, Inc. · 2008
- 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 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K080888Modeification to Iplan RT DoseBrainlab AG · 2008 · cites it directly33descendants
- K103246Iplan RTBrainlab AG · 2011 · 2 generations on32descendants
- K080799Atlas-Based AutosegmentationComputerized Medical Systems, Inc. · 2008 · cites it directly29descendants
- 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) | K053584 | Iplan RT Dose | Brainlab AG | 2006 | — |
| +1 | K080888 | Modeification to Iplan RT Dose | Brainlab AG | 2008 | 3 |
| +2 | K103246 | Iplan RT | Brainlab AG | 2011 | 2 |
| +1 | K080799 | Atlas-Based Autosegmentation | Computerized Medical Systems, Inc. | 2008 | — |
| +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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 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? (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 |
|---|---|---|---|
| * | K994413 | BrainscanSummary page 1…Number 21 CFR 892.5050 Regulatory Class Class 11 FDA Establishment Registration 8043933 Number Predicate Device BrainSCAN (K99441 3) Page 1 of 2 Inten… | 2000 |
What descends from it? (60)
See all 602 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 |
|---|---|---|---|---|
| Nov 19, 2014 | Class II | Z-0957-2015 | Software in the Use Environment | iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets. |
| Nov 19, 2014 | Class II | Z-0956-2015 | Software in the Use Environment | iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets. |
| Jun 5, 2007 | Not classified | Z-1010-2007 | Other | Target Alignment Error : A mechanical component/software incompatibility caused by a specific combination of the BrainLAB Target Positioner version 40700-3A for Leksell headrings and BrainLAB planning software resulted in a 1.25 mm shift… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 7.5 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K080888 (Brainlab AG, 2008) has gone furthest, with 33 descendants of its own.
- 2 other devices also cite its predicate K994413.
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?
iPlan RT Dose 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 as stated in the FDA summary.
https://510kreport.com/device/K053584 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053584: Iplan RT Dose.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053584
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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