Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System— 510(k) K150087

Substantially Equivalent

Ge Vingmed Ultrasound AS

FDA 510(k) clearance K150087 for Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System, Substantially Equivalent on 2015-03-04. Applicant: Ge Vingmed Ultrasound AS.

Clearance details

Applicant: Ge Vingmed Ultrasound AS
Product code: Code IYN
Advisory panel: Radiology
Date received: 2015-01-15
Decision date: 2015-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Horten, NO

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.