# K972324: Leksell Stereotactic System

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instrument AB
- Decided: Mar 2, 1998 after 252 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K892425 (1990). 2 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934523: Gill-Thomas-Cosman (GTC) Relocatable Head Holder System with Depth Confirmation Helmet (DH-1), Radionics, Inc. (1995) Summary page 2.
- K892425: STP Complete Module Set, Leibinger & Fischer, Ltd. (1990) Summary page 2.

## Most influential descendants
- K092192: Waypoint Stereotactic System (2010), 4 descendants of its own
- K132611: Microtable System (2014), 1 descendant of its own
- K233703: Bone Anchor (NGS-BA-01) (2024), 0 descendants of its own
- K231141: STarFix Designer Software C0265 (2023), 0 descendants of its own
- K223552: Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial (2023), 0 descendants of its own

## Recalls of this device
- Oct 2, 2009 · Not classified · Z-1251-2011: New protocols for MR sequences may result in higher RF energies deposited during MR scanning, generating heat in uninsulated fixation posts.

## Indications for use
The Leksell Stereotactic System is a system intended for localization (spatial reference) for cranial surgery using X-Ray, or CT and MRI image data.

Source page: https://510kreport.com/device/K972324
Methodology: https://510kreport.com/methodology