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

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.

Clearance details

Applicant: Elekta Instrument AB
Product code: Code HAW
Advisory panel: Neurology
Date received: 2003-06-27
Decision date: 2003-07-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Stockholm, SE

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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.