FDA Registration
Active
🇯🇵 Japan
LJ BUSINESS CORPORATION
Reg #: 3008632256
·
FEI: 3008632256
·
Expires 2026
Products
12
Proprietary Names
18
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- LJ BUSINESS CORPORATION
- Registration Number
- 3008632256
- FEI Number
- 3008632256
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4F, 2 Chome 2-1, Nihonbashikakigara-Cho
- City
- Chuo Tokyo
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K033737
Owner / Operator
- Firm Name
- LJ Business Corporation
- Operator Number
- 10048369
- Address
- 4F Tomida Building, 2-2-1 Nihonbashi-kakigaracho
- City
- Chuo-ku
- State
- Tokyo
- Postal Code
- 103-0014
- Country
- JP
- Correspondent
- Lijun Huang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2018-11-27 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2018-11-27 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2018-11-27 |
| System, X-Ray, Film Marking, Radiographic | JAC | Class 1 | Radiology | No | 2026-01-15 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2019-07-02 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | Class 2 | Radiology | No | 2023-03-15 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2026-01-28 |
| System, Tomography, Computed, Emission | KPS | Class 2 | Radiology | No | 2023-11-09 |
| Densitometer, Bone | KGI | Class 2 | Radiology | No | 2019-12-09 |
| System, X-Ray, Mammographic | IZH | Class 2 | Radiology | No | 2024-06-19 |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | Class 2 | Radiology | No | 2020-01-16 |
| Coil, Magnetic Resonance, Specialty | MOS | Class 2 | Radiology | No | 2020-01-16 |
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
Establishment Types
Export Device to the United States But Perform No Other Operation on Device