# K973684: Leksell Viewscope, Leksell Surgiscope, Leksell Freehand

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instrument AB
- Decided: Mar 31, 1998 after 186 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: 3 generations back to K911783 (1994). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961639: Leksell Image Guidance Surgical System (Ligs), Elekta Instrument AB (1996) Summary page 2.
- K960714: Isg Viewing Wand, I.S.G. Technologies, Inc. (1996) Summary page 2.
- K970865: Isg Family of Viewing Wands, I.S.G. Technologies, Inc. (1997) Summary page 2.

## Most influential descendants
- 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 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/K973684
Methodology: https://510kreport.com/methodology