OEC One— 510(k) K182626

Substantially Equivalent

Ge Hualun Medical Systems Co. , Ltd.

FDA 510(k) clearance K182626 for OEC One, Substantially Equivalent on 2018-11-16. Applicant: Ge Hualun Medical Systems Co. , Ltd..

Clearance details

Applicant: Ge Hualun Medical Systems Co. , Ltd.
Product code: Code OXO
Advisory panel: Radiology
Date received: 2018-09-24
Decision date: 2018-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code OXO

product code OXO

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.