ASUS Ultrasound Imaging System (LU800 series)— 510(k) K250791

Substantially Equivalent

Asustek Computer, Inc.

FDA 510(k) clearance K250791 for ASUS Ultrasound Imaging System (LU800 series), Substantially Equivalent on 2025-12-04. Applicant: Asustek Computer, Inc..

Clearance details

Applicant: Asustek Computer, Inc.
Product code: Code IYN
Advisory panel: Radiology
Date received: 2025-03-14
Decision date: 2025-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

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.