510(k) · Cleared
ClearedLeksell Gamma Knife Perfexion, Model 715000
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 21, 2006 as substantially equivalent to K984328 (Elekta Instrument AB, 1999) after a 42-day review. Its family tree reaches back 2 generations to 1995. 14 later devices descend from it.
- Decided
- Aug 21, 2006
- Review
- 42 days
- Class
- Class II
- Product code
- IWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K924849 (1995). 14 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK924849 Leksell Gamma Unit Model 23004,Type B.Elekta Radiosurgery, Inc. · 1995
- 1 generation backK984328 Leksell Gamma Knife Target System, Model 24001Elekta Instrument AB · 1999 · Recalled
- This deviceK061941 Leksell Gamma Knife Perfexion, Model 715000Elekta Instrument AB · 2006
- Descendant · cites it directly · 11 of its ownK063512 Leksell Gamma Knife PerfexionElekta Instrument AB · 2007 · Recalled
- Descendant · 2 generations on · 7 of its ownK120811 Leksell Gamma Knife PerfexionElekta Instrument AB · 2012 · Recalled
- Descendant · 3 generations on · 6 of its ownK133565 Leksell Gamma Knife PerfexionElekta Instrument AB · 2014
- Descendant · 4 generations on · 4 of its ownK151159 Leksell Gamma Knife PerfexionElekta Instrument AB · 2015 · Recalled
- Descendant · 4 generations on · 4 of its ownK151561 Leksell Gamma Knife IconElekta Instrument AB · 2015 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K063512Leksell Gamma Knife PerfexionElekta Instrument AB · 2007 · cites it directly11descendants
- K120811Leksell Gamma Knife PerfexionElekta Instrument AB · 2012 · 2 generations on7descendants
- K133565Leksell Gamma Knife PerfexionElekta Instrument AB · 2014 · 3 generations on6descendants
- K151159Leksell Gamma Knife PerfexionElekta Instrument AB · 2015 · 4 generations on4descendants
- K151561Leksell Gamma Knife IconElekta Instrument AB · 2015 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K924849 | Leksell Gamma Unit Model 23004,Type B. | Elekta Radiosurgery, Inc. | 1995 | — |
| −1 | K984328 | Leksell Gamma Knife Target System, Model 24001 | Elekta Instrument AB | 1999 | 4 |
| 0 (this device) | K061941 | Leksell Gamma Knife Perfexion, Model 715000 | Elekta Instrument AB | 2006 | — |
| +1 | K063512 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | 2007 | 4 |
| +2 | K120811 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | 2012 | 1 |
| +3 | K133565 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | 2014 | — |
| +4 | K151159 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | 2015 | 1 |
| +4 | K151561 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K984328 | Leksell Gamma Knife Target System, Model 24001Summary page 1…being claimed 510(k) # Leksell Gamma Knife Target System, Model 24001 K984328 5. Other relevantsubmissions Devices… | 1999 |
What descends from it? (14)
See all 142 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K063512 (Elekta Instrument AB, 2007) has gone furthest, with 11 descendants 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.
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® PERFEXION TM is a teletherapy device intended for use in the stereotactic irradiation of intra-cranial structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061941 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061941: Leksell Gamma Knife Perfexion, Model 715000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061941
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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