Company profile

Ge Hualun Medical Systems Co. , Ltd.

Ge Hualun Medical Systems Co. , Ltd. has 2 AI-enabled medical devices on the FDA list. The first decision was on August 28, 2025 and the most recent on November 26, 2025 (OEC One CFD). Its most common review panel is Radiology (2 devices).

2AI devices

2025First decision

2025Latest decision

1Specialties

Related guides

Top radiology devices

Timeline

November 26, 2025 · 510(k) K253269OEC One CFD · Radiology · OXO
August 28, 2025 · 510(k) K250788Definium Tempo Select · Radiology · KPR