ADVANTAGE WINDOWS CT/PET FUSION— 510(k) K010336

Substantially Equivalent

Ge Medical Systems, Inc.

FDA 510(k) clearance K010336 for ADVANTAGE WINDOWS CT/PET FUSION, Substantially Equivalent on 2001-02-16. Applicant: Ge Medical Systems, Inc..

Clearance details

Applicant: Ge Medical Systems, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2001-02-05
Decision date: 2001-02-16
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.