GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM— 510(k) K101149

Substantially Equivalent

Ge Vingmed Ultrasound AS

FDA 510(k) clearance K101149 for GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM, Substantially Equivalent on 2010-10-13. Applicant: Ge Vingmed Ultrasound AS.

Clearance details

Applicant: Ge Vingmed Ultrasound AS
Product code: Code IYO
Advisory panel: Radiology
Date received: 2010-04-23
Decision date: 2010-10-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Wauwatosa, WI, US

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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.