GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND— 510(k) K091374

Name: FDA 510(k) clearance K091374
Creator: U.S. Food and Drug Administration
Published: 2009-05-26

Substantially Equivalent

Ge Medical Systems China Co., Ltd.

FDA 510(k) clearance K091374 for GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND, Substantially Equivalent on 2009-05-26. Applicant: Ge Medical Systems China Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ge Medical Systems China Co., Ltd.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2009-05-11
Decision date: 2009-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuxi, Jiangsu Province, CN

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 →

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