Data / Medical devices / South Korea / SG Healthcare Co Ltd

SG Healthcare Co Ltd: FDA-registered device maker in Moga-myeon, Icheon-si Gyeonggi, South Korea, 15 510(k) clearances

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

SG Healthcare Co Ltd is registered with the FDA (registration 3009715136) in Moga-myeon, Icheon-si Gyeonggi, South Korea. It lists 14 device types. The FDA files 15 510(k) clearances under its listings, the newest dated January 9, 2024. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3009715136
Address: 10, Yangnyeong-ro, Moga-myeon, Icheon-si Gyeonggi, South Korea, 17408
Owner or operator: SG Healthcare Co. Ltd (10046997)
Roles: Exporter to the US, Manufacturer, Repackager or relabeler
First device listed: June 11, 2014
Registered through: 2026
Brand names listed: EVA HF 525, G10, G5, GARION, Garion, Hasla, INVICTUS, Invictus 1.5 and more

Devices it lists

Device	Product code	Class	Role	Source
Generator, High-Voltage, X-Ray, Diagnostic	IZO	1	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Image-Intensified Fluoroscopic X-Ray System, Mobile	OXO	2	Repackager or relabeler	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
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
System, Nuclear Magnetic Resonance Imaging	LNH	2	Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Angiographic	IZI	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Mobile	IZL	2	Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Stationary	KPR	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Table, Radiographic, Non-Tilting, Powered	IZZ	2	Repackager or relabeler	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Repackager or relabeler	accessdata.fda.gov
X-Ray, Tomography, Computed, Dental	OAS	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
January 9, 2024	K232710	Dental Cone-beam Computed Tomography	OAS	Substantially Equivalent	Yian Medical Technology (Haining) Co., Ltd.	accessdata.fda.gov
February 23, 2023	K230241	Jumong General	KPR	Substantially Equivalent	Sg Healthcare Co, Ltd.	accessdata.fda.gov
October 6, 2022	K222080	Garion Image-Intensified Fluoroscopic X-Ray System, Mobile	OWB	Substantially Equivalent	Sg Healthcare Co, Ltd.	accessdata.fda.gov
July 7, 2017	K170480	Models 3543A, 4343A, 2929A and A843B	MQB	Substantially Equivalent	Shanghai PZ Medical Technolgoy Co., Ltd.	accessdata.fda.gov
May 8, 2015	K150816	Jumong Series	KPR	Substantially Equivalent	Sg Healthcare Co, Ltd.	accessdata.fda.gov
June 14, 2013	K130801	DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM	IYN	Substantially Equivalent	Sonoscape Company Limited	accessdata.fda.gov
October 19, 2012	K122173	DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
July 26, 2011	K110942	PICA WHOLE-BODY MRI SYSTEM	LNH	Substantially Equivalent	Time Medical Limited	accessdata.fda.gov
October 19, 2010	K102023	DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C	IYN	Substantially Equivalent	Shantou Institute of Ultrasonic Instruments (Siui	accessdata.fda.gov
October 7, 2009	K091918	ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO	OWB	Substantially Equivalent	Genoray Co., Ltd.	accessdata.fda.gov
August 6, 2008	K082100	ALLTECH ECHOSTAR 1.5 T MR SYSTEM	LNH	Substantially Equivalent	Alltech Medical Systems America, Inc.	accessdata.fda.gov
June 22, 2007	K071401	X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM	KPR	Substantially Equivalent	Imaging Dynamics Company , Ltd.	accessdata.fda.gov
June 30, 2006	K061488	CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM	IYN	Substantially Equivalent	Shantou Institute of Ultrasonic Instruments (Siui	accessdata.fda.gov
February 2, 2004	K032628	PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF	IZL	Substantially Equivalent	United Radiology Systems, Inc.	accessdata.fda.gov
September 15, 2000	K002685	CORDLESS COMPACT MOBILE X-RAY SYSTEM	IZL	Substantially Equivalent	Medison Radiology Systems, Inc.	accessdata.fda.gov

Compare with other makers

Updated January 9, 2024. 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.