510(k) · Cleared
Recalled · Class II · 2025Leksell GammaPlan
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 3, 2015 as substantially equivalent to K103093 (Elekta Instrument AB, 2010) after a 76-day review. Its family tree reaches back 7 generations to 1992. 4 later devices descend from it. It has been recalled once.
- Decided
- Sep 3, 2015
- Review
- 76 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K914808 (1992). 31 ancestors in all, the oldest K862643 (1987). 4 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK914808 Leksell Gammaplan (LGP)Elekta Instruments, Inc. · 1992
- 6 generations backK973441 Leksell GammaplanPatterson Consulting Group, Inc. · 1998 · Recalled
- 5 generations backK042269 Leksell Gammaplan 4C with MultiviewElekta Instrument AB · 2004
- 4 generations backK051022 GammaplanElekta Instrument AB · 2005
- 3 generations backK061540 Leksell GammaplanElekta Instrument AB · 2006
- 2 generations backK090972 Leksell GammaplanElekta Instrument AB · 2009
- 1 generation backK103093 Leksell GammaplanElekta Instrument AB · 2010 · Recalled
- This deviceK151666 Leksell GammaPlanElekta Instrument AB · 2015
- Descendant · cites it directly · 3 of its ownK173791 Leksell GammaPlanElekta Instrument AB · 2018 · Recalled
- Descendant · 2 generations on · 1 of its ownK193459 Panther StereotacticProwess, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK232854 Leksell GammaPlan (LGP)Elekta Solutions AB · 2024
- Descendant · 3 generations on · 0 of its ownK231825 Panther TPSProwess, Inc. · 2023
Most influential descendants
Showing 4 of 4 · See all- K173791Leksell GammaPlanElekta Instrument AB · 2018 · cites it directly3descendants
- K193459Panther StereotacticProwess, Inc. · 2020 · 2 generations on1descendant
- K232854Leksell GammaPlan (LGP)Elekta Solutions AB · 2024 · 2 generations on0descendants
- K231825Panther TPSProwess, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K914808 | Leksell Gammaplan (LGP) | Elekta Instruments, Inc. | 1992 | — |
| −6 | K973441 | Leksell Gammaplan | Patterson Consulting Group, Inc. | 1998 | 4 |
| −5 | K042269 | Leksell Gammaplan 4C with Multiview | Elekta Instrument AB | 2004 | — |
| −4 | K051022 | Gammaplan | Elekta Instrument AB | 2005 | — |
| −3 | K061540 | Leksell Gammaplan | Elekta Instrument AB | 2006 | — |
| −2 | K090972 | Leksell Gammaplan | Elekta Instrument AB | 2009 | — |
| −1 | K103093 | Leksell Gammaplan | Elekta Instrument AB | 2010 | 1 |
| 0 (this device) | K151666 | Leksell GammaPlan | Elekta Instrument AB | 2015 | — |
| +1 | K173791 | Leksell GammaPlan | Elekta Instrument AB | 2018 | 2 |
| +2 | K193459 | Panther Stereotactic | Prowess, Inc. | 2020 | — |
| +2 | K232854 | Leksell GammaPlan (LGP) | Elekta Solutions AB | 2024 | — |
| +3 | K231825 | Panther TPS | Prowess, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K103093 | Leksell GammaplanSummary page 4…e Identification Legally marketed devices to which equivalence is being claimed 510(k) # Leksell GammaPlan® K103093 5. Other relevant submissions Devices 510(k) # Leks… | 2010 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173791 | Leksell GammaPlan | 2018 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 12, 2025 | Class II | Z-1339-2026 | Use error | Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 7 of the 31 ancestors have a recall of any class.
- Of its descendants, K173791 (Elekta Instrument AB, 2018) has gone furthest, with 3 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. 2015, 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?
Leksell GammaPlan® is a computer-based system designed for Leksell Gamma Knife® treatment planning.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151666: Leksell GammaPlan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151666
Report an extraction error
Are you the manufacturer?
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