# K033340: Leksell Surgiplan with Imagemerge

- Pathway: 510(k) (Special)
- Applicant: Elekta Instrument AB
- Decided: Feb 12, 2004 after 118 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
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K080250: Leksell Surgiplan, Model 1006947 (2008), 5 descendants of its own
- 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

## Indications for use
The Leksell SurgiPlan® with ImageMerge TM accessory is a computer system intended for use in planning invasive intra-cranial stereotactic surgical procedures

Source page: https://510kreport.com/device/K033340
Methodology: https://510kreport.com/methodology