FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)— 510(k) K223902

Substantially Equivalent

Echosens

FDA 510(k) clearance K223902 for FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630), Substantially Equivalent on 2023-03-02. Applicant: Echosens.

Clearance details

Applicant: Echosens
Product code: Code IYO
Advisory panel: Radiology
Date received: 2022-12-28
Decision date: 2023-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

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.