Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems— 510(k) K191007

Substantially Equivalent

Supersonic Imagine

FDA 510(k) clearance K191007 for Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems, Substantially Equivalent on 2019-10-25. Applicant: Supersonic Imagine.

Clearance details

Applicant: Supersonic Imagine
Product code: Code IYN
Advisory panel: Radiology
Date received: 2019-04-16
Decision date: 2019-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aix-En-Provence Cedex, FR

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.