510(k) · Cleared
Recalled · Class II · 2016Leksell Gamma Knife Icon
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 Aug 4, 2015 as substantially equivalent to K133565 (Elekta Instrument AB, 2014) and 1 other predicate after a 55-day review. Its family tree reaches back 9 generations to 1995. 4 later devices descend from it. It has been recalled once.
- Decided
- Aug 4, 2015
- Review
- 55 days
- Class
- Class II
- Product code
- IWB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 9 generations to K926449 (1995). 42 ancestors in all, the oldest K864886 (1987). 4 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 5 generations between
- 3 generations backK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
- 2 generations backK123291 TruebeamVarian Medical Systems, Inc. · 2012
- 1 generation backK131965 XVI R5.0Elekta Limited · 2013
- This deviceK151561 Leksell Gamma Knife IconElekta Instrument AB · 2015
- Descendant · cites it directly · 3 of its ownK160440 Leksell Gamma Knife IconElekta Instrument AB · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK173789 Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB · 2018
- Descendant · 3 generations on · 1 of its ownK222047 Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell…Elekta Solutions AB · 2022
- Descendant · 4 generations on · 0 of its ownK250391 Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™)…Elekta Solutions AB · 2025 · Recalled
Show all 9 generations
- Root · 9 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 8 generations backK973889 Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc. · 1997
- 7 generations backK990085 Millennium MLC -120Varian Assoc., Inc. · 1999 · Recalled
- 6 generations backK050442 Millennium Multi-Leaf CollimatorVarian Medical Systems · 2005 · Recalled
- 5 generations backK071992 High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems · 2007 · Recalled
- 4 generations backK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
- 3 generations backK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
- 2 generations backK123291 TruebeamVarian Medical Systems, Inc. · 2012
- 1 generation backK131965 XVI R5.0Elekta Limited · 2013
- This deviceK151561 Leksell Gamma Knife IconElekta Instrument AB · 2015
Most influential descendants
Showing 4 of 4 · See all- K160440Leksell Gamma Knife IconElekta Instrument AB · 2016 · cites it directly3descendants
- K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB · 2018 · 2 generations on2descendants
- K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta…Elekta Solutions AB · 2022 · 3 generations on1descendant
- K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife®…Elekta Solutions AB · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K926449 | Varian Multileaf Collimator, Release 4.0 | Varian Assoc., Inc. | 1995 | — |
| −8 | K973889 | Varian Multileaf Collimator with Dynamic Arc Therapy Feature | Varian Medical Systems, Inc. | 1997 | — |
| −7 | K990085 | Millennium MLC -120 | Varian Assoc., Inc. | 1999 | 2 |
| −6 | K050442 | Millennium Multi-Leaf Collimator | Varian Medical Systems | 2005 | 2 |
| −5 | K071992 | High-Definition 120 Multileaf Collimator (HD120 MLC) | Varian Medical Systems | 2007 | 4 |
| −4 | K092871 | Trilogy MX | Varian Medical Systems, Inc. | 2009 | 5 |
| −3 | K111106 | Truebeam | Varian Medical Systems, Inc. | 2011 | 5 |
| −2 | K123291 | Truebeam | Varian Medical Systems, Inc. | 2012 | — |
| −1 | K131965 | XVI R5.0 | Elekta Limited | 2013 | — |
| 0 (this device) | K151561 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2015 | — |
| +1 | K160440 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2016 | 1 |
| +2 | K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon | Elekta Instrument AB | 2018 | — |
| +3 | K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife -… | Elekta Solutions AB | 2022 | — |
| +4 | K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell… | Elekta Solutions AB | 2025 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K133565 | Leksell Gamma Knife PerfexionSummary page 4…Manufacturer 510(k) # equivalence is being claimed Leksell Gamma Knife® Perfexion™ Elekta Instrument AB K133565 XVI R5.0 Elekta LTD. K131965 6. Other relevant submi… | 2014 |
| * | K131965 | XVI R5.0Summary page 4…ma Knife® Perfexion™ Elekta Instrument AB K133565 XVI R5.0 Elekta LTD. K131965 6. Other relevant submissions Devices… | 2013 |
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 |
|---|---|---|---|
| K160440 | Leksell Gamma Knife Icon | 2016 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 19, 2016 | Class II | Z-1561-2016 | Use error | The latches of the frame adapter can be locked even if the locating pins of the frame adapter is not inserted into the corresponding holes in the coordinate frame. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 27 of the 42 ancestors have a recall of any class.
- Of its descendants, K160440 (Elekta Instrument AB, 2016) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K133565.
How does its category compare?
All IWB devicesIWB System, Radiation Therapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Gamma Knife® Icon™ is a teletherapy device intended for stereotactic irradiation of head structures ranging from
very small target sizes of a few millimeters to several centimeters, e.g. metastatic tumors, arteriovenous malformations,
trigeminal neuralgia, medically refractory essential tremor, meningiomas, vestibular schwannomas, post-surgical pituitary
adenomas and recurrent glioblastomas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151561 · printed Nov 4, 2026
Cite this page
510(k) Report. “K151561: Leksell Gamma Knife Icon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K151561
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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