510(k) · Cleared
Recalled · Class II · 2017Leksell 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 Apr 20, 2016 as substantially equivalent to K151159 (Elekta Instrument AB, 2015) and 1 other predicate after a 63-day review. Its family tree reaches back 10 generations to 1995. 3 later devices descend from it. It has been recalled once.
- Decided
- Apr 20, 2016
- Review
- 63 days
- Class
- Class II
- Product code
- IWB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 10 generations to K926449 (1995). 49 ancestors in all, the oldest K864886 (1987). 3 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 6 generations between
- 3 generations backK123291 TruebeamVarian Medical Systems, Inc. · 2012
- 2 generations backK131965 XVI R5.0Elekta Limited · 2013
- 1 generation backK151561 Leksell Gamma Knife IconElekta Instrument AB · 2015 · Recalled
- This deviceK160440 Leksell Gamma Knife IconElekta Instrument AB · 2016
- Descendant · cites it directly · 2 of its ownK173789 Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB · 2018
- Descendant · 2 generations on · 1 of its ownK222047 Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell…Elekta Solutions AB · 2022
- Descendant · 3 generations on · 0 of its ownK250391 Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™)…Elekta Solutions AB · 2025 · Recalled
Show all 10 generations
- Root · 10 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 9 generations backK973889 Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc. · 1997
- 8 generations backK990085 Millennium MLC -120Varian Assoc., Inc. · 1999 · Recalled
- 7 generations backK050442 Millennium Multi-Leaf CollimatorVarian Medical Systems · 2005 · Recalled
- 6 generations backK071992 High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems · 2007 · Recalled
- 5 generations backK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
- 4 generations backK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
- 3 generations backK123291 TruebeamVarian Medical Systems, Inc. · 2012
- 2 generations backK131965 XVI R5.0Elekta Limited · 2013
- 1 generation backK151561 Leksell Gamma Knife IconElekta Instrument AB · 2015 · Recalled
- This deviceK160440 Leksell Gamma Knife IconElekta Instrument AB · 2016
Most influential descendants
Showing 3 of 3 · See all- K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB · 2018 · cites it directly2descendants
- K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta…Elekta Solutions AB · 2022 · 2 generations on1descendant
- K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife®…Elekta Solutions AB · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K926449 | Varian Multileaf Collimator, Release 4.0 | Varian Assoc., Inc. | 1995 | — |
| −9 | K973889 | Varian Multileaf Collimator with Dynamic Arc Therapy Feature | Varian Medical Systems, Inc. | 1997 | — |
| −8 | K990085 | Millennium MLC -120 | Varian Assoc., Inc. | 1999 | 2 |
| −7 | K050442 | Millennium Multi-Leaf Collimator | Varian Medical Systems | 2005 | 2 |
| −6 | K071992 | High-Definition 120 Multileaf Collimator (HD120 MLC) | Varian Medical Systems | 2007 | 4 |
| −5 | K092871 | Trilogy MX | Varian Medical Systems, Inc. | 2009 | 5 |
| −4 | K111106 | Truebeam | Varian Medical Systems, Inc. | 2011 | 5 |
| −3 | K123291 | Truebeam | Varian Medical Systems, Inc. | 2012 | — |
| −2 | K131965 | XVI R5.0 | Elekta Limited | 2013 | — |
| −1 | K151561 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2015 | 1 |
| 0 (this device) | K160440 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2016 | — |
| +1 | K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon | Elekta Instrument AB | 2018 | — |
| +2 | K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife -… | Elekta Solutions AB | 2022 | — |
| +3 | 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 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K151159 | Leksell Gamma Knife PerfexionSummary page 4…Manufacturer 510(k) # equivalence is being claimed Leksell Gamma Knife® Perfexion™ Elekta Instrument AB K151159 Leksell Gamma Knife® Icon™ Elekta Instrument AB K151561 6. Other relevant submi… | 2015 |
| * | K151561 | Leksell Gamma Knife IconSummary page 4…mma Knife® Perfexion™ Elekta Instrument AB K151159 Leksell Gamma Knife® Icon™ Elekta Instrument AB K151561 6. Other relevant submissions Devices… | 2015 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon | 2018 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 23, 2017 | Class II | Z-2697-2017 | Other | If the gantry module is replaced after original installation the configuration settings may be missing. The identified risk for this issue is electrical safety for technicians doing maintenance on the X-ray generator. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 34 of the 49 ancestors have a recall of any class.
- Of its descendants, K173789 (Elekta Instrument AB, 2018) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K151159.
How does its category compare?
All IWB devicesIWB System, Radiation Therapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 ∙ Recurrent glioblastomas ∙ Trigeminal neuralgia ∙ Medically refractory essential tremor ∙ Orbital tumors ∙ Ocular tumors ∙ Optic nerve tumors ∙ Benign diseases (such as meningiomas, vestibular schwannomas, post-surgical pituitary adenomas…
Read the full statement (124 words)
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
∙ Recurrent glioblastomas
∙ Trigeminal neuralgia
∙ Medically refractory essential tremor
∙ Orbital tumors
∙ Ocular tumors
∙ Optic nerve tumors
∙ Benign diseases (such as meningiomas, vestibular schwannomas, post-surgical pituitary adenomas, craniopharyngioma, hemangioblastomas, schwannomas, arteriovenous malformations, cavernous malformations, chordomas, glomus tumors, hemangiomas)
∙ Skull base tumors
∙ Head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, oropharynx, nasopharynx, sinonasal, salivary gland)
∙ Pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, cavernous malformations, skull base tumors).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160440 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160440: 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/K160440
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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