GE DIASONICS GATEWAY AND GATEWAY FX— 510(k) K993069

Substantially Equivalent

General Electric Co.

FDA 510(k) clearance K993069 for GE DIASONICS GATEWAY AND GATEWAY FX, Substantially Equivalent on 1999-09-22. Applicant: General Electric Co..

Clearance details

Applicant: General Electric Co.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1999-09-13
Decision date: 1999-09-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.