FibroScan 530 Compact— 510(k) K160524

Substantially Equivalent

Echosens

FDA 510(k) clearance K160524 for FibroScan 530 Compact, Substantially Equivalent on 2016-03-18. Applicant: Echosens.

Clearance details

Applicant: Echosens
Product code: Code IYO
Advisory panel: Radiology
Date received: 2016-02-25
Decision date: 2016-03-18
Decision: Substantially Equivalent
Clearance type: Special
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.