# K080250: Leksell Surgiplan, Model 1006947

- Pathway: 510(k) (Special)
- Applicant: Elekta Instrument AB
- Decided: May 13, 2008 after 103 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K033340 (2004). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033340: Leksell Surgiplan with Imagemerge, Elekta Instrument AB (2004) Summary page 1.

## Most influential descendants
- K092192: Waypoint Stereotactic System (2010), 4 descendants of its own
- K132611: Microtable System (2014), 1 descendant of its own
- K233703: Bone Anchor (NGS-BA-01) (2024), 0 descendants of its own
- K231141: STarFix Designer Software C0265 (2023), 0 descendants of its own
- K223552: Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial (2023), 0 descendants of its own

## Indications for use
Leksell SurgiPlan®is intended for use in planning invasive intracranial stereotactic surgical procedures.

Source page: https://510kreport.com/device/K080250
Methodology: https://510kreport.com/methodology