SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM— 510(k) K093714

Clearance details

Applicant

Medison Co., Ltd.

Product code

Code ITX

Device class

Class 2

Regulation

21 CFR 892.1570

Advisory panel

Radiology

Date received

2009-12-02

Decision date

2009-12-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Seoul, KR

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Death

6

Injury

137

Malfunction

2,036

Total

2,179

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 →