NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25)— 510(k) K242681

Substantially Equivalent

Nurodata, Inc.

FDA 510(k) clearance K242681 for NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25), Substantially Equivalent on 2025-02-20. Applicant: Nurodata, Inc..

Clearance details

Applicant: Nurodata, Inc.
Product code: Code IYN
Advisory panel: Radiology
Date received: 2024-09-06
Decision date: 2025-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhubei, 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.