GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM— 510(k) K120201

Name: FDA 510(k) clearance K120201
Creator: U.S. Food and Drug Administration
Published: 2012-04-19

Substantially Equivalent

Ge Vingmed Ultrasound AS

FDA 510(k) clearance K120201 for GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM, Substantially Equivalent on 2012-04-19. Applicant: Ge Vingmed Ultrasound AS. Device class: 2.

Clearance details

Applicant: Ge Vingmed Ultrasound AS
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2012-01-23
Decision date: 2012-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wauwatosa, WI, US

Download summary PDF View on FDA.gov ↗

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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 →

Recalls naming K120201

K-number listed on FDA's recall record

Z-0373-2014 — GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers and several real time 3D transducers. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, LCD color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.Class II·Terminated·GE Healthcare, LLC·20131011

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120201.

Data sourced from openFDA. This site is unofficial and independent of the FDA.