# K992882: Leksell Image Guidance Surgical System, View Scope, Surgiscope,Elekta Insight

- Pathway: 510(k) (Special)
- Applicant: Elekta Instrument AB
- Decided: Sep 24, 1999 after 29 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: 4 generations back to K911783 (1994). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973684: Leksell Viewscope, Leksell Surgiscope, Leksell Freehand, Elekta Instrument AB (1998) Summary page 1.
- K983831: VECTORVISION2, Brainlab AG (1999) Summary page 1.

## Indications for use
The Leksell® Image Guidance Surgical System (LIGS) is intended for use in cranial and spinal 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/K992882
Methodology: https://510kreport.com/methodology