Medical Device Manufacturer · US , Kirkland , WA

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

26 submissions · 26 cleared · Since 2011

Recent clearances: X-CUBE 50, X-CUBE 60, X-CUBE 70, X-CUBE 90, X-CUBE 50, X-CUBE 60

26
Total
26
Cleared
0
Denied

FDA 510(k) Regulatory Record - Alpinion Medical Systems Co., Ltd. Radiology ✕

26 devices
1-12 of 26
Cleared Apr 17, 2023
X-CUBE 50, X-CUBE 60
K223564 · IYN
Radiology · 139d
Cleared Oct 14, 2022
X-CUBE 70, X-CUBE 90
K221093 · IYN
Radiology · 184d
Cleared Oct 13, 2022
X-CUBE 50, X-CUBE 60
K220857 · IYN
Radiology · 204d
Cleared Jan 28, 2022
X-CUBE i8, X-CUBE i9
K213523 · IYN
Radiology · 86d
Cleared Aug 09, 2021
X-CUBE 70
K211299 · IYN
Radiology · 103d
Cleared Aug 09, 2021
X-CUBE 90
K211300 · IYN
Radiology · 103d
Cleared Jul 10, 2020
X-Cube 90
K200449 · IYN
Radiology · 137d
Cleared Jul 10, 2020
X-Cube 70
K200450 · IYN
Radiology · 137d
Cleared Jan 24, 2019
E-CUBE i7
K182594 · IYN
Radiology · 126d
Cleared Dec 27, 2018
minisono
K182845 · IYN
Radiology · 79d
Cleared Oct 11, 2018
E-CUBE 8
K181617 · IYN
Radiology · 114d
Cleared Sep 28, 2018
E-CUBE 12
K181277 · IYN
Radiology · 137d
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