Data / Medical devices / Japan / Everx Japan Co. Ltd

Everx Japan Co. Ltd: FDA-registered device maker in Kawasaki Kanagawa, Japan, 6 510(k) clearances

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

Everx Japan Co. Ltd is registered with the FDA (registration 3014343100) in Kawasaki Kanagawa, Japan. It lists 8 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 8, 2020. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Everx Japan Co. Ltd

FDA registration number: 3014343100
Address: 1F Kowa Kawasaki Nishiguchi Building 66-2 Horikawa-Cho, Saiwai-Ku, Kawasaki Kanagawa, Japan, 2120013
Owner or operator: Everx Japan Co. Ltd (10064022)
Roles: Exporter to the US, Remanufacturer, Repackager or relabeler
First device listed: March 23, 2020
Registered through: 2026
Brand names listed: Allura XPER FD Series FD 20/20, GE Innova IGS Cath Angio, K083852 Siemens Biograph 16 True Point PET/CT, Philips Allura XPer Cath Angio, Siemens SOMATOM Definition AS+, system, nuclear magnetic resonance imaging

Devices it lists

Device	Product code	Class	Role	Source
Coil, Magnetic Resonance, Specialty	MOS	2	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
System, Nuclear Magnetic Resonance Spectroscopic	LNI	2	Exporter to the US, Repackager or relabeler	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, Remanufacturer, Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Exporter to the US, Repackager or relabeler	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
September 8, 2020	K202014	Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit	LNH	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
June 27, 2019	K190578	SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence	JAK	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov
August 19, 2014	K141979	ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES	OWB	Substantially Equivalent	Philips Medical Systems Netherland BV	accessdata.fda.gov
May 21, 2013	K130842	ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES	IZI	Substantially Equivalent	Philips Medical Systems Nederland B.V.	accessdata.fda.gov
January 2, 2013	K122457	GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS	OWB	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
March 23, 2009	K083852	BIOGRAPH 16 TRUE POINT SYSTEMS	KPS	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov

Compare with other makers

Updated September 8, 2020. 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.