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 · IWB System, Radiation Therapy, Radionuclide
Cleared on Feb 9, 2018 as substantially equivalent to K151666 (Elekta Instrument AB, 2015) after a 57-day review. Its family tree reaches back 8 generations to 1992. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 9, 2018
- Review
- 57 days
- Class
- Class II
- Product code
- IWB
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 8 generations to K914808 (1992). 32 ancestors in all, the oldest K862643 (1987). 3 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK914808 Leksell Gammaplan (LGP)Elekta Instruments, Inc. · 1992
- 7 generations backK973441 Leksell GammaplanPatterson Consulting Group, Inc. · 1998 · Recalled
- 6 generations backK042269 Leksell Gammaplan 4C with MultiviewElekta Instrument AB · 2004
- 5 generations backK051022 GammaplanElekta Instrument AB · 2005
- 4 generations backK061540 Leksell GammaplanElekta Instrument AB · 2006
- 3 generations backK090972 Leksell GammaplanElekta Instrument AB · 2009
- 2 generations backK103093 Leksell GammaplanElekta Instrument AB · 2010 · Recalled
- 1 generation backK151666 Leksell GammaPlanElekta Instrument AB · 2015 · Recalled
- This deviceK173791 Leksell GammaPlanElekta Instrument AB · 2018
- Descendant · cites it directly · 1 of its ownK193459 Panther StereotacticProwess, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK232854 Leksell GammaPlan (LGP)Elekta Solutions AB · 2024
- Descendant · 2 generations on · 0 of its ownK231825 Panther TPSProwess, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K914808 | Leksell Gammaplan (LGP) | Elekta Instruments, Inc. | 1992 | — |
| −7 | K973441 | Leksell Gammaplan | Patterson Consulting Group, Inc. | 1998 | 4 |
| −6 | K042269 | Leksell Gammaplan 4C with Multiview | Elekta Instrument AB | 2004 | — |
| −5 | K051022 | Gammaplan | Elekta Instrument AB | 2005 | — |
| −4 | K061540 | Leksell Gammaplan | Elekta Instrument AB | 2006 | — |
| −3 | K090972 | Leksell Gammaplan | Elekta Instrument AB | 2009 | — |
| −2 | K103093 | Leksell Gammaplan | Elekta Instrument AB | 2010 | 1 |
| −1 | K151666 | Leksell GammaPlan | Elekta Instrument AB | 2015 | 1 |
| 0 (this device) | K173791 | Leksell GammaPlan | Elekta Instrument AB | 2018 | — |
| +1 | K193459 | Panther Stereotactic | Prowess, Inc. | 2020 | — |
| +1 | K232854 | Leksell GammaPlan (LGP) | Elekta Solutions AB | 2024 | — |
| +2 | 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 |
|---|---|---|
| 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 IWB? 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 IWB device
- #1 K250391 Leksell Gamma Knife® (Elekta Esprit); Leksell…score 11.2 · 13 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 |
|---|---|---|---|
| * | K151666 | Leksell GammaPlanSummary page 4…Identification Legally marketed devices to which equivalence is being claimed 510(k) # Leksell GammaPlan® K151666 6. Other relevant submissions Device 510(k) # Leksell Ga… | 2015 |
What descends from it? (3)
2 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 |
|---|---|---|---|---|
| Dec 12, 2025 | Class II | Z-1340-2026 | 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… |
| Jun 27, 2018 | Class II | Z-1412-2019 | Software design | The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 8 of the 32 ancestors have a recall of any class.
- Of its descendants, K193459 (Prowess, Inc., 2020) has gone furthest, with 1 descendant of its own.
How does its category compare?
All IWB devicesIWB System, Radiation Therapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · IWB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IWB
57in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IWB
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IWB
3in 2025
MAUDE reports naming product code IWB, 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 | 1 | — | 3 | 8 |
| 2008 | 0 | — | 3 | 15 |
| 2009 | 1 | — | 1 | 8 |
| 2010 | 0 | — | 1 | 9 |
| 2011 | 1 | — | 2 | 5 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 3 | 170 | 1 | 8 |
| 2015 | 3 | 79 | 0 | 5 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 3 | 57 | 0 | 2 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
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/K173791 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173791: 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/K173791
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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