# K943468: Leksell Surgiplan

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instruments, Inc.
- Decided: Jan 20, 1995 after 185 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K961639: Leksell Image Guidance Surgical System (Ligs) (1996), 2 descendants of its own
- K973684: Leksell Viewscope, Leksell Surgiscope, Leksell Freehand (1998), 1 descendant of its own
- K013861: Modification to Leksell Surgiplan with Atlaspace (2001), 0 descendants of its own
- K992882: Leksell Image Guidance Surgical System, View Scope, Surgiscope,Elekta Insight (1999), 0 descendants of its own

## Recalls of this device
- May 23, 2005 · Not classified · Z-1428-2010: Images from a different patient can be imported without a warning for the user.

Source page: https://510kreport.com/device/K943468
Methodology: https://510kreport.com/methodology