510(k) · Cleared
Recalled · 2011Leksell Gamma Knife Target System, Model 24001
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 May 21, 1999 as substantially equivalent to K924849 (Elekta Radiosurgery, Inc., 1995) after a 169-day review. Its family tree reaches back 1 generation to 1995. 15 later devices descend from it. It has been recalled 4 times.
- Decided
- May 21, 1999
- Review
- 169 days
- Class
- Class II
- Product code
- IWB
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924849 (1995). 15 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK924849 Leksell Gamma Unit Model 23004,Type B.Elekta Radiosurgery, Inc. · 1995
- This deviceK984328 Leksell Gamma Knife Target System, Model 24001Elekta Instrument AB · 1999
- Descendant · cites it directly · 14 of its ownK061941 Leksell Gamma Knife Perfexion, Model 715000Elekta Instrument AB · 2006
- Descendant · 2 generations on · 11 of its ownK063512 Leksell Gamma Knife PerfexionElekta Instrument AB · 2007 · Recalled
- Descendant · 3 generations on · 7 of its ownK120811 Leksell Gamma Knife PerfexionElekta Instrument AB · 2012 · Recalled
- Descendant · 4 generations on · 6 of its ownK133565 Leksell Gamma Knife PerfexionElekta Instrument AB · 2014
- Descendant · 5 generations on · 4 of its ownK151159 Leksell Gamma Knife PerfexionElekta Instrument AB · 2015 · Recalled
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K061941Leksell Gamma Knife Perfexion, Model 715000Elekta Instrument AB · 2006 · cites it directly14descendants
- K063512Leksell Gamma Knife PerfexionElekta Instrument AB · 2007 · 2 generations on11descendants
- K120811Leksell Gamma Knife PerfexionElekta Instrument AB · 2012 · 3 generations on7descendants
- K133565Leksell Gamma Knife PerfexionElekta Instrument AB · 2014 · 4 generations on6descendants
- K151159Leksell Gamma Knife PerfexionElekta Instrument AB · 2015 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924849 | Leksell Gamma Unit Model 23004,Type B. | Elekta Radiosurgery, Inc. | 1995 | — |
| 0 (this device) | K984328 | Leksell Gamma Knife Target System, Model 24001 | Elekta Instrument AB | 1999 | — |
| +1 | K061941 | Leksell Gamma Knife Perfexion, Model 715000 | Elekta Instrument AB | 2006 | — |
| +2 | K063512 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | 2007 | 4 |
| +3 | K120811 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | 2012 | 1 |
| +4 | K133565 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | 2014 | — |
| +5 | K151159 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K924849 | Leksell Gamma Unit Model 23004,Type B.Summary page 1…ionuclide Radiation Therapy Device 21 CFR 892.5750 19.3 IDENTIFICATION OF PREDICATE DEVICE Company Device 510(k) No. Date Cleared Elekta Instruments Leksell Gamma Unit K924849 November 20, 1995 Model 23004, Type B Leksell® Gamma Knife Target System Model 24001 Original Premarket 510(k) No… | 1995 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061941 | Leksell Gamma Knife Perfexion, Model 715000 | 2006 | 14 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 26, 2011 | Not classified | Z-0312-2012 | Pending | Several of the LMR03 actuators with bronze drive nut have failed unexpectedly, creating a potential safety hazard for the operator and patient. |
| Oct 1, 2007 | Not classified | Z-1236-2010 | Other | After updating the LGK actuator in spare part 810361, the old sleigh became obsolete due to causing insufficient locking of the helmet in combination with the new actuator. |
| Sep 1, 2006 | Not classified | Z-1533-2010 | Other | Leksell Gamma Knife C 1.2 with MCU version 4.0.0.6 improperly adjusted trolley for 4mm helmet caused jamming when helmet changer attempted to lock helmet. Lock did not fully engage and could still be raised. When the lock does not engage… |
| Aug 1, 2006 | Not classified | Z-1429-2010 | Other | Due to a material change in a critical component of the linear actuators the quality of said part was found to be inadequate. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K061941 (Elekta Instrument AB, 2006) has gone furthest, with 14 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?
The Leksell® Gamma Knife Target System Model 24001 is a teletherapy device indicated for use in the stereotactic irradiation of intracranial structures
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/K984328 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984328: Leksell Gamma Knife Target System, Model 24001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984328
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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