K3900 Ultrasound Imaging System— 510(k) K230511

Substantially Equivalent

Maui Imaging

FDA 510(k) clearance K230511 for K3900 Ultrasound Imaging System, Substantially Equivalent on 2023-10-25. Applicant: Maui Imaging.

Clearance details

Applicant: Maui Imaging
Product code: Code IYO
Advisory panel: Radiology
Date received: 2023-02-24
Decision date: 2023-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, 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.