510(k) · Cleared
Recalled · Class II · 2026Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta Solutions AB · IWB System, Radiation Therapy, Radionuclide
Cleared on Jul 2, 2025 as substantially equivalent to K222047 (Elekta Solutions AB, 2022) after a 140-day review. Its family tree reaches back 13 generations to 1995. It has been recalled once.
- Decided
- Jul 2, 2025
- Review
- 140 days
- Class
- Class II
- Product code
- IWB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 13 generations to K926449 (1995). 52 ancestors in all, the oldest K864886 (1987). No later device cites it as a predicate yet.
- Root · 13 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 9 generations between
- 3 generations backK160440 Leksell Gamma Knife IconElekta Instrument AB · 2016 · Recalled
- 2 generations backK173789 Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB · 2018
- 1 generation backK222047 Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell…Elekta Solutions AB · 2022
- This deviceK250391 Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™)…Elekta Solutions AB · 2025
Show all 13 generations
- Root · 13 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 12 generations backK973889 Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc. · 1997
- 11 generations backK990085 Millennium MLC -120Varian Assoc., Inc. · 1999 · Recalled
- 10 generations backK050442 Millennium Multi-Leaf CollimatorVarian Medical Systems · 2005 · Recalled
- 9 generations backK071992 High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems · 2007 · Recalled
- 8 generations backK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
- 7 generations backK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
- 6 generations backK123291 TruebeamVarian Medical Systems, Inc. · 2012
- 5 generations backK131965 XVI R5.0Elekta Limited · 2013
- 4 generations backK151561 Leksell Gamma Knife IconElekta Instrument AB · 2015 · Recalled
- 3 generations backK160440 Leksell Gamma Knife IconElekta Instrument AB · 2016 · Recalled
- 2 generations backK173789 Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB · 2018
- 1 generation backK222047 Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell…Elekta Solutions AB · 2022
- This deviceK250391 Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™)…Elekta Solutions AB · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K926449 | Varian Multileaf Collimator, Release 4.0 | Varian Assoc., Inc. | 1995 | — |
| −12 | K973889 | Varian Multileaf Collimator with Dynamic Arc Therapy Feature | Varian Medical Systems, Inc. | 1997 | — |
| −11 | K990085 | Millennium MLC -120 | Varian Assoc., Inc. | 1999 | 2 |
| −10 | K050442 | Millennium Multi-Leaf Collimator | Varian Medical Systems | 2005 | 2 |
| −9 | K071992 | High-Definition 120 Multileaf Collimator (HD120 MLC) | Varian Medical Systems | 2007 | 4 |
| −8 | K092871 | Trilogy MX | Varian Medical Systems, Inc. | 2009 | 5 |
| −7 | K111106 | Truebeam | Varian Medical Systems, Inc. | 2011 | 5 |
| −6 | K123291 | Truebeam | Varian Medical Systems, Inc. | 2012 | — |
| −5 | K131965 | XVI R5.0 | Elekta Limited | 2013 | — |
| −4 | K151561 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2015 | 1 |
| −3 | K160440 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2016 | 1 |
| −2 | K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon | Elekta Instrument AB | 2018 | — |
| −1 | K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife -… | Elekta Solutions AB | 2022 | — |
| 0 (this device) | K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell… | Elekta Solutions AB | 2025 | — |
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 |
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 K222047 Leksell Gamma Knife Perfexion, Leksell Gamma…score 10.5 · 12 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 |
|---|---|---|---|
| * | K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta…Summary page 5…iation therapy system Regulation Number 892.5750 Product Code IWB III. Predicate Device Predicate # K222047 Predicate Trade Name Leksell Gamma Knife® (Elekta Esprit, Icon™, and Perfexion™) Predicate Product Code… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 18, 2026 | Class II | Z-1581-2026 | Use error | Due to adapter not being properly aligned or locked in place. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 35 of the 52 ancestors have a recall of any class.
How does its category compare?
All IWB devicesIWB System, Radiation Therapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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® 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 (150 words)
Leksell Gamma Knife® 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)
* Refractory mesial temporal lobe epilepsy in adults
* Refractory epilepsy associated with structural changes such as hamartomas, cerebral cavernous malformations, and arteriovenous malformations (adult and pediatric)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250391 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250391: Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250391
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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