EVERX JAPAN CO. LTD

FDA Device Registration & Listing · Kawasaki Kanagawa, JP · Registration 3014343100

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014343100
FEI Number
3014343100
Entity Name
EVERX JAPAN CO. LTD
City/State/Country
Kawasaki Kanagawa, JP
Establishment Address
1F Kowa Kawasaki Nishiguchi Building, 66-2 Horikawa-Cho, Saiwai-Ku, Kawasaki Kanagawa 2120013, JP
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Remanufacture Medical Device
Owner / Operator
Everx Japan Co. Ltd (Owner Number: 10064022)
Owner / Operator Contact Address
1F Kowa Kawasaki Nishiguchi Building, 66-2 Horikawa-Cho, Saiwai-Ku, Kawasaki, JP-14 2120013, JP
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K130842
PMA Number
N/A

All Registered Proprietary Names

Allura XPER FD Series FD 20/20 K083852 Siemens Biograph 16 True Point PET/CT GE Innova IGS Cath Angio system, nuclear magnetic resonance imaging Philips Allura XPer Cath Angio

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2020-03-23
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2020-03-23
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2026-03-23
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-03-23
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2025-01-29
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2025-01-29
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2025-01-29
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2021-10-20
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2021-10-20
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2021-10-20
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2025-01-07

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Everx Japan Co. Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K163715 Philips Medical Systems Nederland B.V. Allura Xper R9 2017-01-26
K863853 Superior Medical Products EAZY COVERS 1987-03-06
K953974 Medivision Medical Imaging, Ltd. CAMVISION 1000 1996-09-09
K024012 Ge Oec Medical Systems OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM 2003-03-20
K970608 Guidant Cardiac and Vascular Surgery EVT MARKER BOARD 1997-04-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands 2
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0002-2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands 2
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0003-2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands 2
Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0004-2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands 2
Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0005-2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands 2
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014343100. Last updated year: 2026. Please use registration number 3014343100 when referencing this establishment in official correspondence.
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