Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008632256

FEI Number

3008632256

Entity Name

LJ BUSINESS CORPORATION

City/State/Country

Chuo Tokyo, JP

Establishment Address

4F, 2 Chome 2-1, Nihonbashikakigara-Cho, Chuo Tokyo 103-0014, JP

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

LJ Business Corporation (Owner Number: 10048369)

Owner / Operator Contact Address

4F Tomida Building, 2-2-1 Nihonbashi-kakigaracho, Chuo-ku, JP-13 103-0014, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K132410

PMA Number

N/A

All Registered Proprietary Names

Philips Angio Allura Xper FD20 SIEMENS SOMATOM Force GE CT Optima 660 GE LightSpeed 16 GE C-Arm OEC 9900 Magnetom Skyra Siemens PETCT Biograph SIEMENS CT SOMATOM Force GE Bonedensitometer Prodigy SIEMENS Angio Artis Zee GE CT LightSpeed VCT HOLOGIC Mammography Selenia Dimensions GE MRI Signa HDxt 1.5T Biograph mCT SIEMENS SPECT Symbia SPECT MAGNETOM AERA; MAGNETOM SKYRA GE PETCT Discovery STE GE CT Optima580

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	2018-11-27
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2018-11-27
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2018-11-27
JAC	System, X-Ray, Film Marking, Radiographic	Radiology	Class 1	892.1640	2026-01-15
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-07-02
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2018-06-19
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2023-03-15
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2023-03-15
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2023-03-15
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2026-01-28
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2023-11-09
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-11-09
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-01-15
KGI	Densitometer, Bone	Radiology	Class 2	892.1170	2019-12-09
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2024-11-28
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2018-02-21
IZH	System, X-Ray, Mammographic	Radiology	Class 2	892.1710	2024-06-19
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2020-01-16
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2020-01-16
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2020-01-16
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2026-01-28
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-01-28
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-01-15
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2026-01-15
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2024-11-28
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2019-12-09
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-12-09
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2019-03-09

Official Correspondent

Lijun Huang

US Agent Details

YOLANDA PENA Email: redmedicalsolutions@outlook.com Phone: (631) 5798304

Related Public Records

Same Entity

LJ Business Corporation

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;

Similar Registrations

Registration Number	Establishment Name	Location
3021027284	ANGIOWAVE IMAGING, INC.	Concord, MA, US
3042175844	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	BEST Noord-Brabant, NL
3027373189	LIBERTY GLOBAL, LLC	Scottsdale, AZ, US
3033527282	Philips India Limited - Image Guided Therapy Systems Business Unit	Bengaluru Karnataka, IN
9614698	CANON INC.	OTAWARA-SHI Tochigi, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008632256. Last updated year: 2026. Please use registration number 3008632256 when referencing this establishment in official correspondence.