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Ge Hualun Medical Systems Co. , Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253269OEC One CFDNovember 26, 2025
K250788Definium Tempo SelectAugust 28, 2025
K240828OEC One ASDDecember 27, 2024
K242678Definium Pace Select ETOctober 1, 2024
K231892Definium Pace SelectSeptember 12, 2023
K191699Discovery XR656 HD with VolumeRadJuly 24, 2019
K182626OEC OneNovember 16, 2018
K173612Optima XR646 HDDecember 11, 2017
K172700OEC OneNovember 9, 2017
K172869Discovery XR656 HDOctober 20, 2017
K171800OEC Elite MiniViewJuly 12, 2017
K143270Optima XR646February 18, 2015