K253269

Substantially Equivalent

OEC One CFD

Applicant: Ge Hualun Medical Systems Co. , Ltd.
Product code: OXO
Advisory panel: Radiology
Date received: 2025-09-29
Decision date: 2025-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

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.