GE LOGIQ I, LOGIQ E AND VIVID E— 510(k) K113690

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K113690 for GE LOGIQ I, LOGIQ E AND VIVID E, Substantially Equivalent on 2011-12-29. Applicant: GE Healthcare.

Clearance details

Applicant: GE Healthcare
Product code: Code IYN
Advisory panel: Radiology
Date received: 2011-12-15
Decision date: 2011-12-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Wauwatosa, WI, US

Download summary PDF View on FDA.gov ↗

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.