Medical Device Manufacturer · CN , Beijing

Ge Hualun Medical Systems Co. , Ltd. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2015

Recent clearances: OEC One CFD, Definium Tempo Select, OEC One ASD

Total

Cleared

Denied

Ge Hualun Medical Systems Co. , Ltd. has 12 FDA 510(k) cleared radiology devices. Based in Beijing, CN.

Latest FDA clearance: Nov 2025. Active since 2015.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by GE Healthcare as regulatory consultant.

Ge Hualun Medical Systems Co. , Ltd. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Ge Hualun Medical Systems Co. , Ltd.

12 devices

1-12 of 12

Definium Tempo Select

Definium Pace Select ET

Discovery XR656 HD with VolumeRad

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: Apr 27, 2026

Ge Hualun Medical Systems Co. , Ltd. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Ge Hualun Medical Systems Co. , Ltd.

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