# K961639: Leksell Image Guidance Surgical System (Ligs)

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instrument AB
- Decided: Jul 26, 1996 after 88 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 K920689 (1993). 4 ancestors in all.
2 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)
- K943468: Leksell Surgiplan, Elekta Instruments, Inc. (1995) Summary page 3.
- K920689: Deemed MSS -- Microscope Support System, Deemed, Inc. (1993) Summary page 3.
- K954276: Stealthstation, Surgical Navigation Technologies, Inc. (1996) Summary page 3.
- K942233: MKM (Multiple Coordinate Manipulator) System, Carl Zeiss, Inc. (1994) Summary page 3.

## Most influential descendants
- K973684: Leksell Viewscope, Leksell Surgiscope, Leksell Freehand (1998), 1 descendant of its own
- K992882: Leksell Image Guidance Surgical System, View Scope, Surgiscope,Elekta Insight (1999), 0 descendants of its own

## Indications for use
The Leksell Image Guidance Surgical System (LIGS) is intended for use in neurosurgical procedures to provide image guidance based on preoperative images which are visualized interactively with the aid of surgical tools.

Source page: https://510kreport.com/device/K961639
Methodology: https://510kreport.com/methodology