ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT— 510(k) K031999

Name: FDA 510(k) clearance K031999
Creator: U.S. Food and Drug Administration
Published: 2003-07-25

Substantially Equivalent

Elekta Instrument AB

FDA 510(k) clearance K031999 for ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT, Substantially Equivalent on 2003-07-25. Applicant: Elekta Instrument AB. Device class: 2.

Clearance details

Applicant: Elekta Instrument AB
Product code: Code HAW
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2003-06-27
Decision date: 2003-07-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Stockholm, SE

Download summary PDF View on FDA.gov ↗

Recent devices under product code HAW

view all

K253856 — Geniant Cranial (Navigated Neurosurgical Positioning Robot)2026-09-10
K261932 — Leksell® Vantage Stereotactic System2026-08-05
K253663 — Zeta Navigation System2026-05-01
K253379 — Stealth AXiS Cranial clinical application2026-03-26
K231897 — NeuroAlign software2025-10-21

More clearances from Elekta Instrument AB

view all

K190887 — Leksell Vantage Stereotactic System2019-08-01
K173789 — Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon2018-03-30
K173791 — Leksell GammaPlan2018-02-09
K171123 — Leksell Vantage Stereotactic System2017-09-15
K160440 — Leksell Gamma Knife Icon2016-04-20

Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.