Ge Hualun Medical Systems Co. , Ltd. - FDA 510(k) Cleared Devices
12
Total
12
Cleared
0
Denied
FDA 510(k) cleared devices by Ge Hualun Medical Systems Co. , Ltd. Radiology ✕
12 devices
Cleared
Nov 26, 2025
OEC One CFD
Radiology
58d
Cleared
Aug 28, 2025
Definium Tempo Select
Radiology
167d
Cleared
Dec 27, 2024
OEC One ASD
Radiology
276d
Cleared
Oct 01, 2024
Definium Pace Select ET
Radiology
25d
Cleared
Sep 12, 2023
Definium Pace Select
Radiology
76d
Cleared
Jul 24, 2019
Discovery XR656 HD with VolumeRad
Radiology
29d
Cleared
Nov 16, 2018
OEC One
Radiology
53d
Cleared
Dec 11, 2017
Optima XR646 HD
Radiology
19d
Cleared
Nov 09, 2017
OEC One
Radiology
63d
Cleared
Oct 20, 2017
Discovery XR656 HD
Radiology
30d
Cleared
Jul 12, 2017
OEC Elite MiniView
Radiology
26d
Cleared
Feb 18, 2015
Optima XR646
Radiology
97d