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

Medicaps Co., Ltd.: FDA-registered device maker in Seongnam-si Gyeonggi, South Korea, 5 510(k) clearances

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

Medicaps Co., Ltd. is registered with the FDA (registration 3026391023) in Seongnam-si Gyeonggi, South Korea. It lists 7 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 9, 2016. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3026391023
Address: 202-ho, New Seonkyung Plaza, 13 Imae-ro, Bundang-gu, Seongnam-si Gyeonggi, South Korea, 13564
Owner or operator: Medicaps Co., Ltd (10092335)
Roles: Exporter to the US, Manufacturer
First device listed: December 24, 2024
Registered through: 2026
Brand names listed: GE Discovery 690 PET/CT, GE Discovery MR750, Parts for Brilliance iCT 256, Philips Allura FD20, Philips Brilliance CT, Siemens Artis Zee Cath Angio

Devices it lists

Device	Product code	Class	Role	Source
Interventional Fluoroscopic X-Ray System	OWB	2	Exporter to the US	accessdata.fda.gov
Support, Breathing Tube	JAY	1	Manufacturer	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Exporter to the US	accessdata.fda.gov
System, Tomography, Computed, Emission	KPS	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Angiographic	IZI	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Exporter to the US	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
June 9, 2016	K160618	Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
June 18, 2009	K090745	ARTIS ZEE / ZEEGOS WITH SW VC14	IZI	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
June 12, 2008	K081496	OPTIMA PET/CT 560	KPS	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
September 8, 2004	K042293	BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER	JAK	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.	accessdata.fda.gov
December 9, 2003	K033737	ALLURA XPER FD20	OWB	Substantially Equivalent	Philips Medical Systems North America, Inc.	accessdata.fda.gov

Compare with other makers

Updated June 9, 2016. 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.