X-Cube 70

System, Imaging, Pulsed Doppler, Ultrasonic

Alpinion Medical Systems Co., Ltd.

The following data is part of a premarket notification filed by Alpinion Medical Systems Co., Ltd. with the FDA for X-cube 70.

Pre-market Notification Details

Device IDK200450
510k NumberK200450
Device Name:X-Cube 70
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Alpinion Medical Systems Co., Ltd. 5FL, I Dong, 77, Heungan-daero 81 Beon-gil Dongan-gu Anyang-si,  KR 14117
ContactBoyeon Cho
CorrespondentBoyeon Cho
Alpinion Medical Systems Co., Ltd. 5FL, I Dong, 77, Heungan-daero 81 Beon-gil Dongan-gu Anyang-si,  KR 14117
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-24
Decision Date2020-07-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800013540003 K200450 000

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