GE LOGIQ 9 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 2404587— 510(k) K040251

Substantially Equivalent

Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc

FDA 510(k) clearance K040251 for GE LOGIQ 9 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 2404587, Substantially Equivalent on 2004-02-20. Applicant: Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc.

Clearance details

Applicant: Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc
Product code: Code IYN
Advisory panel: Radiology
Date received: 2004-02-03
Decision date: 2004-02-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Milwaukee, 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.