Data / Medical devices / Japan / LJ Business Corporation
LJ Business Corporation: FDA-registered device maker in Chuo Tokyo, Japan, 21 510(k) clearances
LJ Business Corporation is registered with the FDA (registration 3008632256) in Chuo Tokyo, Japan. It lists 12 device types. The FDA files 21 510(k) clearances under its listings, the newest dated July 3, 2025. Registered through 2027. FDA data exported November 3, 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.
- FDA registration number
- 3008632256
- Address
- 4F, 2 Chome 2-1 Nihonbashikakigara-Cho, Chuo Tokyo, Japan, 103-0014
- Owner or operator
- LJ Business Corporation (10048369)
- Roles
- Exporter to the US
- First device listed
- February 21, 2018
- Registered through
- 2027
- Brand names listed
- Biograph mCT, GE Bonedensitometer Prodigy, GE C-Arm OEC 9900, GE CT LightSpeed VCT, GE CT Optima 660, GE CT Optima580, GE CT Revolution Evo, GE LightSpeed 16 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | 2 | Exporter to the US | accessdata.fda.gov |
| Densitometer, Bone | KGI | 2 | Exporter to the US | accessdata.fda.gov |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | 2 | Exporter to the US | accessdata.fda.gov |
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Exporter to the US | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Exporter to the US | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | 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, Film Marking, Radiographic | JAC | 1 | 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, Mammographic | IZH | 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 |
|---|---|---|---|---|---|---|
| July 3, 2025 | K251671 | Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 26, 2024 | K241898 | Symbia SPECT and SPECT/CT Systems | KPS | Substantially Equivalent | Siemens Healthineers | accessdata.fda.gov |
| December 20, 2017 | K173578 | Biograph mCT Family of PET/CT Systems | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 16, 2016 | K163213 | Revolution CT | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| December 2, 2016 | K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17 | KGI | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| November 24, 2015 | K142955 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 17, 2014 | K132410 | DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 30, 2013 | K131576 | OPTIMA CT660 | JAK | Substantially Equivalent | Ge Medical Systems, LLC | 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 |
| September 20, 2012 | K121676 | 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| November 23, 2011 | K111242 | MAGNETOM AERA AND MAGNETOM SKYRA | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 1, 2010 | K101347 | MAGNETOM AERA; MAGNETOM SKYRA | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 6, 2010 | K100692 | DIGITAL SPOT MAMMOGRAPHY SYSTEM | IZH | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| June 18, 2009 | K090745 | ARTIS ZEE / ZEEGOS WITH SW VC14 | IZI | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 23, 2009 | K083852 | BIOGRAPH 16 TRUE POINT SYSTEMS | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 2, 2008 | K082104 | GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, Inc. | accessdata.fda.gov |
| May 2, 2008 | K073543 | OEC 9900 ELITE | OWB | Substantially Equivalent | Ge Oec Medical Systems | accessdata.fda.gov |
| June 22, 2004 | K041543 | GE DISCOVERY ST | KPS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| March 1, 2004 | K040372 | LIGHTSPEED 7.0 CT SCANNER SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, LLC | 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
- All makers of Densitometer, Bone
- All makers of System, Tomography, Computed, Emission
- All makers of System, X-Ray, Tomography, Computed
- All makers of System, X-Ray, Angiographic
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
- All makers of Interventional Fluoroscopic X-Ray System
Updated July 3, 2025. 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.