# K924849: Leksell Gamma Unit Model 23004,Type B.

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Radiosurgery, Inc.
- Decided: Nov 20, 1995 after 1,148 days
- Product code: IWB (System, Radiation Therapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K984328: Leksell Gamma Knife Target System, Model 24001 (1999), 15 descendants of its own
- 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

Source page: https://510kreport.com/device/K924849
Methodology: https://510kreport.com/methodology