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

Infinitt Healthcare Co., Ltd.: FDA-registered device maker in Seoul, South Korea, 17 510(k) clearances

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

Infinitt Healthcare Co., Ltd. is registered with the FDA (registration 3003989064) in Seoul, South Korea. It lists 3 device types. The FDA files 17 510(k) clearances under its listings, the newest dated December 9, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003989064
Address: 12F Daerung Post Tower III 27 Digital-ro 34-gil, Guro-gu, Seoul, 08378, South Korea, Seoul, South Korea, 08378
Owner or operator: INFINITT Healthcare Co., Ltd. (9055477)
Roles: Manufacturer
First device listed: February 20, 2011
Registered through: 2026
Brand names listed: INFINITT Cardiology, INFINITT Cardiology PACS, INFINITT DPS, INFINITT G3, INFINITT G7 PACS, INFINITT MAMMO 7, INFINITT Mammo, INFINITT PACS and more

Devices it lists

Device	Product code	Class	Role	Source
Digital Pathology Image Viewing And Management Software	QKQ	2	Manufacturer	accessdata.fda.gov
System, Digital Image Communications, Radiological	LMD	1	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	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
December 9, 2025	K243449	INFINITT DPS	QKQ	Substantially Equivalent	Infinitt Healthcare Co., Ltd.	accessdata.fda.gov
April 14, 2020	K193369	Xelis Dental 2.0	LLZ	Substantially Equivalent	Infinitt Healthcare Co., Ltd.	accessdata.fda.gov
February 13, 2020	K193498	Infinitt RT PACS	LLZ	Substantially Equivalent	Infinitt Healthcare Co., Ltd.	accessdata.fda.gov
October 27, 2017	K172803	Infinitt PACS 7.0	LLZ	Substantially Equivalent	Infinitt Healthcare Co., Ltd.	accessdata.fda.gov
March 24, 2017	K163290	INFINITT ULite	LLZ	Substantially Equivalent	Infinitt Co., Ltd.	accessdata.fda.gov
September 13, 2011	K111660	XELIS CARDIAC	LLZ	Substantially Equivalent	Infinitt Co., Ltd.	accessdata.fda.gov
September 8, 2011	K111613	XELIS FUSION	LLZ	Substantially Equivalent	Infinitt Co., Ltd.	accessdata.fda.gov
July 28, 2011	K103130	XELIS 3D	LLZ	Substantially Equivalent	Infinitt Co., Ltd.	accessdata.fda.gov
October 1, 2010	K102684	XELIS DENTAL	LLZ	Substantially Equivalent	Infinitt Co., Ltd.	accessdata.fda.gov
November 20, 2008	K082990	INFINITT XELIS	LLZ	Substantially Equivalent	Infinitt Co., Ltd.	accessdata.fda.gov
November 6, 2008	K082706	INFINITT CARDIOLOGY PACS	LLZ	Substantially Equivalent	Infinitt Co., Ltd.	accessdata.fda.gov
November 8, 2005	K052545	INFINITT G3 PACS	LLZ	Substantially Equivalent	Infinitt Co., Ltd.	accessdata.fda.gov
October 17, 2005	K052284	REFORMAT GATEWAY	LLZ	Substantially Equivalent	Infinitt Co., Ltd.	accessdata.fda.gov
August 2, 2005	K051715	STARPACS DENTAL	LLZ	Substantially Equivalent	Infinitt Co., Ltd.	accessdata.fda.gov
July 13, 2004	K041761	RAPIDIACOLON	LLZ	Substantially Equivalent	Infinitt Co., Ltd.	accessdata.fda.gov
June 21, 2004	K041500	STARPACS ORTHOPEDICS SYSTEM	LLZ	Substantially Equivalent	Infinitt Co., Ltd.	accessdata.fda.gov
April 17, 2003	K031013	INFINTT CO., LTD. STARPACS SYSTEM	LLZ	Substantially Equivalent	Infinitt Company	accessdata.fda.gov

Compare with other makers

Updated December 9, 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.