VOLUSON E6/E8/E8EXPERT/E10— 510(k) K113758

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K113758 for VOLUSON E6/E8/E8EXPERT/E10, Substantially Equivalent on 2012-01-10. Applicant: GE Healthcare.

Clearance details

Applicant: GE Healthcare
Product code: Code IYE
Advisory panel: Radiology
Date received: 2011-12-21
Decision date: 2012-01-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Wauwatosa, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.