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Healcerion Co., Ltd: FDA-registered device maker in Seoul, South Korea, 3 510(k) clearances

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

Healcerion Co., Ltd is registered with the FDA (registration 3011648943) in Seoul, South Korea. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 22, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011648943
Address: 1013-Ho, 12 Digital-Ro 33-Gil, Guro-Gu, Seoul, South Korea, 08377
Owner or operator: Healcerion Co., Ltd. (10049969)
Roles: Manufacturer
First device listed: September 18, 2015
Registered through: 2026
Brand names listed: SONON Ultrasound Imaging System (Model: 300L), SONON Ultrasound Imaging System (Model: SONON 300C), SONON Ultrasound Imaging System (Model: SONON 500L)

Devices it lists

Device	Product code	Class	Role	Source
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Manufacturer	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 22, 2022	K212400	SONON Ultrasound Imaging System, Model: SONON 500L	IYN	Substantially Equivalent	Healcerion Co., Ltd.	accessdata.fda.gov
October 12, 2017	K170085	SONON Ultrasound Imaging System, Model: 300L	IYN	Substantially Equivalent	Healcerion Co., Ltd.	accessdata.fda.gov
September 10, 2015	K151339	SONON Ultrasound Imaging System (Model: SONON 300C)	IYO	Substantially Equivalent	Healcerion Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 22, 2022. 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.