ADVANTAGE WINDOWS (AW) FUSION— 510(k) K983256

Substantially Equivalent

GE Medical Systems

FDA 510(k) clearance K983256 for ADVANTAGE WINDOWS (AW) FUSION, Substantially Equivalent on 1998-12-15. Applicant: GE Medical Systems.

Clearance details

Applicant: GE Medical Systems
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1998-09-16
Decision date: 1998-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.