Data / Medical devices / South Korea / Gemss Healthcare Co., Ltd.

Gemss Healthcare Co., Ltd.: FDA-registered device maker in Gyeonggi, South Korea, 7 510(k) clearances

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

Gemss Healthcare Co., Ltd. is registered with the FDA (registration 3030089787) in Gyeonggi, South Korea. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated August 3, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3030089787
Address: 1F, 822, Bogwang-ro, Gwangtan-myeon, Paju-si, Gyeonggi, South Korea, 10952
Owner or operator: GEMSS HEALTHCARE CO., LTD. (10089429)
Roles: Manufacturer
First device listed: December 7, 2023
Registered through: 2026
Brand names listed: HI-300, HI-500, HORIZON, KMC-650, KMC-650P, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 and more

Devices it lists

Device	Product code	Class	Role	Source
Image-Intensified Fluoroscopic X-Ray System, Mobile	OXO	2	Manufacturer	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Mobile	IZL	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Stationary	KPR	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
August 3, 2026	K260236	XLITE	IZL	Substantially Equivalent	GEMSS HEALTHCARE CO., LTD.	accessdata.fda.gov
November 16, 2023	K233200	XPLUS 35 Series (XPLUS 35, XPLUS 35FD)	OWB	Substantially Equivalent	GEMSS HEALTHCARE CO., LTD.	accessdata.fda.gov
November 2, 2023	K230800	XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50	KPR	Substantially Equivalent	GEMSS HEALTHCARE CO., LTD.	accessdata.fda.gov
May 26, 2017	K163140	SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System	OWB	Substantially Equivalent	Gemss Medical Systems Co., Ltd.	accessdata.fda.gov
May 20, 2016	K160065	GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System	OXO	Substantially Equivalent	Gemss Medical Systems Co., Ltd.	accessdata.fda.gov
August 7, 2014	K133695	TITAN 11	KPR	Substantially Equivalent	Gemss Medical Systems Co., Ltd.	accessdata.fda.gov
June 16, 2014	K132289	GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM	JAA	Substantially Equivalent	Gemss Medical Systems Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 3, 2026. 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.