SONALIS, MODEL 2000— 510(k) K043189

Substantially Equivalent

3g Ultrasound, Inc.

FDA 510(k) clearance K043189 for SONALIS, MODEL 2000, Substantially Equivalent on 2005-02-09. Applicant: 3g Ultrasound, Inc..

Clearance details

Applicant: 3g Ultrasound, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2004-11-17
Decision date: 2005-02-09
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Boynton Beach, FL, US

Download summary PDF View on FDA.gov ↗

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.