WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM— 510(k) K090190

Substantially Equivalent

Nuclemed S.A.

FDA 510(k) clearance K090190 for WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM, Substantially Equivalent on 2009-10-09. Applicant: Nuclemed S.A..

Clearance details

Applicant: Nuclemed S.A.
Product code: Code HAW
Advisory panel: Neurology
Date received: 2009-01-26
Decision date: 2009-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hudson, NH, US

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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.