510(k) · Cleared
ClearedLeksell Gammaplan 4C with Multiview
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta Instrument AB · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Sep 8, 2004 as substantially equivalent to K973441 (Patterson Consulting Group, Inc., 1998) after a 16-day review. Its family tree reaches back 2 generations to 1992. 11 later devices descend from it.
- Decided
- Sep 8, 2004
- Review
- 16 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K914808 (1992). 11 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK914808 Leksell Gammaplan (LGP)Elekta Instruments, Inc. · 1992
- 1 generation backK973441 Leksell GammaplanPatterson Consulting Group, Inc. · 1998 · Recalled
- This deviceK042269 Leksell Gammaplan 4C with MultiviewElekta Instrument AB · 2004
- Descendant · cites it directly · 10 of its ownK051022 GammaplanElekta Instrument AB · 2005
- Descendant · 2 generations on · 9 of its ownK061540 Leksell GammaplanElekta Instrument AB · 2006
- Descendant · cites it directly · 6 of its ownK090972 Leksell GammaplanElekta Instrument AB · 2009
- Descendant · 2 generations on · 5 of its ownK103093 Leksell GammaplanElekta Instrument AB · 2010 · Recalled
- Descendant · 3 generations on · 4 of its ownK151666 Leksell GammaPlanElekta Instrument AB · 2015 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K051022GammaplanElekta Instrument AB · 2005 · cites it directly10descendants
- K061540Leksell GammaplanElekta Instrument AB · 2006 · 2 generations on9descendants
- K090972Leksell GammaplanElekta Instrument AB · 2009 · cites it directly6descendants
- K103093Leksell GammaplanElekta Instrument AB · 2010 · 2 generations on5descendants
- K151666Leksell GammaPlanElekta Instrument AB · 2015 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914808 | Leksell Gammaplan (LGP) | Elekta Instruments, Inc. | 1992 | — |
| −1 | K973441 | Leksell Gammaplan | Patterson Consulting Group, Inc. | 1998 | 4 |
| 0 (this device) | K042269 | Leksell Gammaplan 4C with Multiview | Elekta Instrument AB | 2004 | — |
| +1 | K051022 | Gammaplan | Elekta Instrument AB | 2005 | — |
| +2 | K061540 | Leksell Gammaplan | Elekta Instrument AB | 2006 | — |
| +1 | K090972 | Leksell Gammaplan | Elekta Instrument AB | 2009 | — |
| +2 | K103093 | Leksell Gammaplan | Elekta Instrument AB | 2010 | 1 |
| +3 | K151666 | Leksell GammaPlan | Elekta Instrument AB | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K973441 | Leksell GammaplanSummary page 1…ode |Class Regulation Number Radionuclide radiation therapy system |IWB [ 892.5750 4. Regulatory History (Unmodified Predicate Device) Devices 510(k) # Leksell GammaPlan K973441 5. Other relevant submissions Devices 510(k) # Leksell Surgiplan with Atlaspace K013861 Leksell Surgiplan with Imagemerge K033340… | 1998 |
What descends from it? (11)
See all 112 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)
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 12 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K051022 (Elekta Instrument AB, 2005) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K973441.
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?
The Leksell GarmmaPlan 4C with MultiView is a computer-based dose planning system specifically designed for use with the Leksell Gamma Knife®. The Leksell GammaPlan 4C with MultiView is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgey and stereotactic radio therapy. It processes the inputs from the healt care professionals such that the desired radiation dose is provided by the Leksell Gamma Knife® to a precisely defined target area within the cranium.
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/K042269 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042269: Leksell Gammaplan 4C with Multiview.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042269
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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