AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10— 510(k) K180572

Clearance details

Applicant

Supersonic Imagine

Product code

Code IYN

Device class

Class 2

Regulation

21 CFR 892.1550

Advisory panel

Radiology

Date received

2018-03-05

Decision date

2018-05-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Aix-En-Provence Cedex, FR

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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 →