# K984328: Leksell Gamma Knife Target System, Model 24001

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instrument AB
- Decided: May 21, 1999 after 169 days
- Product code: IWB (System, Radiation Therapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5750
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K924849 (1995). 1 ancestor in all.
15 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924849: Leksell Gamma Unit Model 23004,Type B., Elekta Radiosurgery, Inc. (1995) Summary page 1.

## Most influential descendants
- K061941: Leksell Gamma Knife Perfexion, Model 715000 (2006), 14 descendants of its own
- K063512: Leksell Gamma Knife Perfexion (2007), 11 descendants of its own
- K120811: Leksell Gamma Knife Perfexion (2012), 7 descendants of its own
- K133565: Leksell Gamma Knife Perfexion (2014), 6 descendants of its own
- K151159: Leksell Gamma Knife Perfexion (2015), 4 descendants of its own

## Recalls of this device
- May 26, 2011 · Not classified · Z-0312-2012: 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: 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: 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 
- Aug 1, 2006 · Not classified · Z-1429-2010: Due to a material change in a critical component of the linear actuators the quality of said part was found to be inadequate.

## Indications for use
The Leksell® Gamma Knife Target System Model 24001 is a teletherapy device indicated for use in the stereotactic irradiation of intracranial structures

Source page: https://510kreport.com/device/K984328
Methodology: https://510kreport.com/methodology