Data / Medical devices / South Korea / Humanscan Co., Ltd

Humanscan Co., Ltd: FDA-registered device maker in Siheung-si Gyeonggi, South Korea, 20 510(k) clearances

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

Humanscan Co., Ltd is registered with the FDA (registration 3016076141) in Siheung-si Gyeonggi, South Korea. It lists 5 device types. The FDA files 20 510(k) clearances under its listings, the newest dated November 17, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3016076141
Address: 15, Emtibeuibuk-ro 137beon-gil, Siheung-si Gyeonggi, South Korea, 15119
Owner or operator: HUMANSCAN CO., LTD (10026862)
Roles: Manufacturer
First device listed: September 9, 2016
Registered through: 2026
Brand names listed: 18H5, 3Sp, 3Sp-D, 5Sp, 7L2, C2-7VN-D, M5S-D, S1-5-D, C2-7-D, L3-9i-D, C5-2v, CW8 and more

Devices it lists

Device	Product code	Class	Role	Source
Biopsy Needle Guide Kit	OIJ	2	Manufacturer	accessdata.fda.gov
Catheter, Ultrasound, Intravascular	OBJ	2	Manufacturer	accessdata.fda.gov
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
November 17, 2025	K253487	ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System	IYN	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
June 12, 2024	K233610	ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System	IYN	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
September 26, 2023	K232617	ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System	IYN	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
February 13, 2023	K230207	ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System	IYN	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
August 16, 2022	K221190	ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System	IYN	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
February 11, 2022	K213487	ACUSON P500 Ultrasound System	IYN	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
April 17, 2020	K200158	LOGIQ E10	IYN	Substantially Equivalent	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	accessdata.fda.gov
April 15, 2020	K200707	ACUSON Sequoia Diagnostic Ultrasound System	IYN	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
September 20, 2018	K181783	LOGIQ P9; LOGIQ P7	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
February 1, 2018	K180039	ACUSON P600 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
November 17, 2016	K163077	LOGIQ E9, LOGIQ E9 XDClear 2.0	IYN	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics	accessdata.fda.gov
October 3, 2016	K162269	Voluson E6, Voluson E8, Voluson E10	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
July 28, 2016	K161787	ACUSON NX2 Diagnostic Ultrasound Systems	IYN	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
May 5, 2016	K161047	LOGIQ P9 and LOGIQ P7	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
January 29, 2015	K143452	LOGIQ P9, LOGIQ P7	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
June 5, 2014	K141261	LOGIQ S7 EXPERT, LOGIQ S7 PRO	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
August 26, 2013	K131527	LOGIQ S8	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
October 3, 2012	K122114	LOGIQ S7 EXPERT, LOGIQ S7 PRO	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
October 5, 2010	K101874	GE LOGIQ P6/P6 PRO	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
August 31, 2010	K101878	GE LOGIQ P5 MODEL H44662LD	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov

Compare with other makers

Updated November 17, 2025. 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.