Data / Medical devices / South Korea / ALPINION MEDICAL SYSTEMS Co., Ltd.

ALPINION MEDICAL SYSTEMS Co., Ltd.: FDA-registered device maker in Gangseo-gu Seoul, South Korea, 19 510(k) clearances

Name: ALPINION MEDICAL SYSTEMS Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

ALPINION MEDICAL SYSTEMS Co., Ltd. is registered with the FDA (registration 3008950127) in Gangseo-gu Seoul, South Korea. It lists 3 device types. The FDA files 19 510(k) clearances under its listings, the newest dated April 17, 2023. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3008950127
Address: 4F, 15, Magokjungang 14-ro, Gangseo-gu Seoul, South Korea, 07789
Owner or operator: Alpinion Medical Systems Co., Ltd. (10037469)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: January 8, 2013
Registered through: 2026
Brand names listed: C1-6C, C1-6CT, C1-6T, C1-7GT, C5-8, C5-8N, C5-8NT, CW2 and more

Devices it lists

Device	Product code	Class	Role	Source
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 17, 2023	K223564	X-CUBE 50, X-CUBE 60	IYN	Substantially Equivalent	Alpinion Medical Systems Co., Ltd.	accessdata.fda.gov
October 14, 2022	K221093	X-CUBE 70, X-CUBE 90	IYN	Substantially Equivalent	Alpinion Medical Systems Co., Ltd.	accessdata.fda.gov
October 13, 2022	K220857	X-CUBE 50, X-CUBE 60	IYN	Substantially Equivalent	Alpinion Medical Systems Co., Ltd.	accessdata.fda.gov
January 28, 2022	K213523	X-CUBE i8, X-CUBE i9	IYN	Substantially Equivalent	Alpinion Medical Systems Co., Ltd.	accessdata.fda.gov
August 9, 2021	K211300	X-CUBE 90	IYN	Substantially Equivalent	Alpinion Medical Systems Co., Ltd.	accessdata.fda.gov
August 9, 2021	K211299	X-CUBE 70	IYN	Substantially Equivalent	Alpinion Medical Systems Co., Ltd.	accessdata.fda.gov
July 10, 2020	K200450	X-Cube 70	IYN	Substantially Equivalent	Alpinion Medical Systems Co., Ltd.	accessdata.fda.gov
July 10, 2020	K200449	X-Cube 90	IYN	Substantially Equivalent	Alpinion Medical Systems Co., Ltd.	accessdata.fda.gov
January 24, 2019	K182594	E-CUBE i7	IYN	Substantially Equivalent	Alpinion Medical Systems Co., Ltd.	accessdata.fda.gov
December 27, 2018	K182845	minisono	IYN	Substantially Equivalent	Alpinion Medical Systems Co., Ltd.	accessdata.fda.gov
October 11, 2018	K181617	E-CUBE 8	IYN	Substantially Equivalent	Alpinion Medical Systems Co., Ltd.	accessdata.fda.gov
September 28, 2018	K181277	E-CUBE 12	IYN	Substantially Equivalent	Alpinion Medical Systems Co., Ltd.	accessdata.fda.gov
December 14, 2017	K172732	E-CUBE 8	IYN	Substantially Equivalent	Alpinion Medical Systems Co., Ltd.	accessdata.fda.gov
February 26, 2016	K153424	E-CUBE i7	IYN	Substantially Equivalent	Alpinion Medical Systems Co., Ltd.	accessdata.fda.gov
July 23, 2015	K150773	E-CUBE 15 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Alpinion Medical Systems Co., Ltd.	accessdata.fda.gov
October 28, 2014	K142884	E-CUBE 12	IYN	Substantially Equivalent	Alpinion Medical Systems Co., Ltd.	accessdata.fda.gov
October 28, 2014	K142733	E-CUBE 5	IYN	Substantially Equivalent	Alpinion Medical Systems Co., Ltd.	accessdata.fda.gov
February 1, 2013	K123610	E-CUBE 15	IYN	Substantially Equivalent	Alpinion Medical Systems Co., Ltd.	accessdata.fda.gov
July 26, 2012	K121888	E-CUBE 15	IYO	Substantially Equivalent	Alpinion Medical Systems Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 17, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.