Data / Medical devices / United States / Alpinion Usa

Alpinion Usa: FDA-registered device maker in Bothell, WA, United States, 9 510(k) clearances

Name: Alpinion Usa FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Alpinion Usa is registered with the FDA (registration 3009293490) in Bothell, WA, United States. It lists 3 device types. The FDA files 9 510(k) clearances under its listings, the newest dated December 14, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009293490
Address: 21222 30th Dr SE Ste C-122, Bothell, WA, United States, 98021
Owner or operator: Alpinion USA (10042979)
Roles: Repackager or relabeler
First device listed: January 16, 2013
Registered through: 2026
Brand names listed: E-Cube 11, E-Cube 12, E-Cube 15, E-Cube 5, E-Cube 7, E-Cube 8, E-Cube 9, E-Cube Inno and more

Devices it lists

Device	Product code	Class	Role	Source
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Repackager or relabeler	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Repackager or relabeler	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Repackager or relabeler	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
December 14, 2017	K172732	E-CUBE 8	IYN	Substantially Equivalent	Alpinion Medical Systems Co., Ltd.	accessdata.fda.gov
September 21, 2016	K161439	E-CUBE 11	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
November 27, 2013	K132687	E-CUBE 7	IYN	Substantially Equivalent	Alpinion Medical Systems Co., Ltd.	accessdata.fda.gov
July 26, 2012	K121937	E-CUBE INNO	IYN	Substantially Equivalent	Alpinion Medical Systems Co., Ltd.	accessdata.fda.gov
March 16, 2012	K120060	E-CUBE 9	IYN	Substantially Equivalent	Alpinion Medical Systems Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated December 14, 2017. 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.