Medical Device Manufacturer · CN , Beijing

Ge Hualun Medical Systems Co. , Ltd.

12 submissions · 12 cleared · Since 2015
12
Total
12
Cleared
0
Denied

Ge Hualun Medical Systems Co. , Ltd. — FDA 510(k) Submissions

Ge Hualun Medical Systems Co. , Ltd. has submitted 12 FDA 510(k) premarket notifications since 2015, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, X-ray, Stationary, Image-intensified Fluoroscopic X-ray System, Mobile, Interventional Fluoroscopic X-ray System . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
OEC One CFD
K253269 · OXO Image-intensified... · Radiology
Nov 2025 58d
Definium Tempo Select
K250788 · KPR System, X-ray, Stationary · Radiology
Aug 2025 167d
OEC One ASD
K240828 · OXO Image-intensified... · Radiology
Dec 2024 276d
Definium Pace Select ET
K242678 · KPR System, X-ray, Stationary · Radiology
Oct 2024 25d
Definium Pace Select
K231892 · KPR System, X-ray, Stationary · Radiology
Sep 2023 76d
Discovery XR656 HD with VolumeRad
K191699 · KPR System, X-ray, Stationary · Radiology
Jul 2019 29d
OEC One
K182626 · OXO Image-intensified... · Radiology
Nov 2018 53d
Optima XR646 HD
K173612 · KPR System, X-ray, Stationary · Radiology
Dec 2017 19d
OEC One
K172700 · OWB Interventional... · Radiology
Nov 2017 63d
Discovery XR656 HD
K172869 · KPR System, X-ray, Stationary · Radiology
Oct 2017 30d
OEC Elite MiniView
K171800 · OXO Image-intensified... · Radiology
Jul 2017 26d
Optima XR646
K143270 · KPR System, X-ray, Stationary · Radiology
Feb 2015 97d
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