Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)— 510(k) K233401

Substantially Equivalent

Eieling Technology Limited

FDA 510(k) clearance K233401 for Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile), Substantially Equivalent on 2024-02-12. Applicant: Eieling Technology Limited.

Clearance details

Applicant: Eieling Technology Limited
Product code: Code IYO
Advisory panel: Radiology
Date received: 2023-10-04
Decision date: 2024-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, CN

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.