GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4— 510(k) K092271

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K092271 for GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4, Substantially Equivalent on 2009-11-17. Applicant: GE Healthcare.

Clearance details

Applicant: GE Healthcare
Product code: Code IYN
Advisory panel: Radiology
Date received: 2009-07-28
Decision date: 2009-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

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Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

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.