# K261932: Leksell® Vantage Stereotactic System

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Solutions AB
- Decided: Aug 5, 2026 after 57 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 K031999 (2003). 5 ancestors in all.
No later device cites it as a predicate yet.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190887: Leksell Vantage Stereotactic System, Elekta Instrument AB (2019) Summary page 5.
- K152558: Leksell Stereotactic System, Injection/ Aspiration Needle Kit, Elekta Instrument AB (2016) Summary page 5.

## Indications for use
The intended purpose of Leksell® Vantage Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures; for example deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.

Source page: https://510kreport.com/device/K261932
Methodology: https://510kreport.com/methodology