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
08800013540003 K200450 000
08800013540003 K200450 000
08800013540003 K200450 000
08800013540003 K200450 000
08800013540003 K200450 000
08800013540003 K200450 000
08800013540003 K200450 000
08800013540003 K200450 000
08800013540003 K200450 000
08800013540003 K200450 000
08800013540003 K200450 000
08800013540003 K200450 000
08800013540003 K200450 000

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