# K031999: Elekta Leksell Stereotactic System with MR Post Kit

- Pathway: 510(k) (Special)
- Applicant: Elekta Instrument AB
- Decided: Jul 25, 2003 after 28 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
No predicates in its family tree.
6 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K080355: Leksell Stereotactic System with Reusable Fixation Screws (2009), 5 descendants of its own
- K171123: Leksell Vantage Stereotactic System (2017), 4 descendants of its own
- K190887: Leksell Vantage Stereotactic System (2019), 3 descendants of its own
- K210700: NaviNetics D1 Stereotactic System (2021), 1 descendant of its own
- K261932: Leksell® Vantage Stereotactic System (2026), 0 descendants of its own

## Indications for use
The Leksell Stereotactic System with MR post kit is a system intended for localization and diagnosis of intracranial disorders and their surgical treatment, including radiotherapy and stereotactic radiaton therapy

Source page: https://510kreport.com/device/K031999
Methodology: https://510kreport.com/methodology