510(k) · Cleared
Recalled · 2009Leksell Gamma Knife Perfexion
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 Mar 5, 2007 as substantially equivalent to K061941 (Elekta Instrument AB, 2006) after a 105-day review. Its family tree reaches back 3 generations to 1995. 11 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 5, 2007
- Review
- 105 days
- Class
- Class II
- Product code
- IWB
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 3 generations to K924849 (1995). 11 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK924849 Leksell Gamma Unit Model 23004,Type B.Elekta Radiosurgery, Inc. · 1995
- 2 generations backK984328 Leksell Gamma Knife Target System, Model 24001Elekta Instrument AB · 1999 · Recalled
- 1 generation backK061941 Leksell Gamma Knife Perfexion, Model 715000Elekta Instrument AB · 2006
- This deviceK063512 Leksell Gamma Knife PerfexionElekta Instrument AB · 2007
- Descendant · cites it directly · 7 of its ownK120811 Leksell Gamma Knife PerfexionElekta Instrument AB · 2012 · Recalled
- Descendant · 2 generations on · 6 of its ownK133565 Leksell Gamma Knife PerfexionElekta Instrument AB · 2014
- Descendant · 3 generations on · 4 of its ownK151159 Leksell Gamma Knife PerfexionElekta Instrument AB · 2015 · Recalled
- Descendant · 3 generations on · 4 of its ownK151561 Leksell Gamma Knife IconElekta Instrument AB · 2015 · Recalled
- Descendant · 4 generations on · 3 of its ownK160440 Leksell Gamma Knife IconElekta Instrument AB · 2016 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K120811Leksell Gamma Knife PerfexionElekta Instrument AB · 2012 · cites it directly7descendants
- K133565Leksell Gamma Knife PerfexionElekta Instrument AB · 2014 · 2 generations on6descendants
- K151159Leksell Gamma Knife PerfexionElekta Instrument AB · 2015 · 3 generations on4descendants
- K151561Leksell Gamma Knife IconElekta Instrument AB · 2015 · 3 generations on4descendants
- K160440Leksell Gamma Knife IconElekta Instrument AB · 2016 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924849 | Leksell Gamma Unit Model 23004,Type B. | Elekta Radiosurgery, Inc. | 1995 | — |
| −2 | K984328 | Leksell Gamma Knife Target System, Model 24001 | Elekta Instrument AB | 1999 | 4 |
| −1 | K061941 | Leksell Gamma Knife Perfexion, Model 715000 | Elekta Instrument AB | 2006 | — |
| 0 (this device) | K063512 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | 2007 | — |
| +1 | K120811 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | 2012 | 1 |
| +2 | K133565 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | 2014 | — |
| +3 | K151159 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | 2015 | 1 |
| +3 | K151561 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2015 | 1 |
| +4 | K160440 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 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 |
|---|---|---|---|
| * | K061941 | Leksell Gamma Knife Perfexion, Model 715000Summary page 1…m. [IWB 11 21 CFR 892.5750 4. Predicate Device Identification Legally marketed devices to which equivalence is being claimed 510(k) # Leksell Gamma Knife® PERFEXION ™ K061941 S. Other relevant submissions Devices 510(k) # Leksell Steretocatic System K972324 Leksell GammaPlan® PFX K061540 Elekta Inst… | 2006 |
What descends from it? (11)
See all 112 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 |
|---|---|---|---|---|
| Nov 6, 2009 | Not classified | Z-1232-2010 | Software design | There may be a situation where the Frame Adapter might lock the stereotactic Frame in the wrong position. |
| Nov 9, 2008 | Not classified | Z-1230-2010 | Software design | Radiation unit doors could close too fast on emergency exit. |
| Jul 2, 2007 | Not classified | Z-1158-2010 | Other | Need to modify the closing speed of the shielding doors in the event of an emergency exit |
| May 30, 2007 | Not classified | Z-1231-2010 | Software design | There has been an issue with "Image Fushing" where low precision calculation caused images to become inaccurate. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K120811 (Elekta Instrument AB, 2012) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K061941.
How does its category compare?
All IWB devicesIWB System, Radiation Therapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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®PERFEXION TM 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K063512 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063512: 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/K063512
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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