OEC One— 510(k) K182626

Clearance details

Applicant

Ge Hualun Medical Systems Co. , Ltd.

Product code

Code OXO

Device class

Class 2

Regulation

21 CFR 892.1650

Advisory panel

Radiology

Date received

2018-09-24

Decision date

2018-11-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Beijing, CN

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Death

6

Injury

163

Malfunction

2,099

Other

1

Total

2,269

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 →