Data / Medical devices / Japan / Fujita Co., Ltd.
Fujita Co., Ltd.: FDA-registered device maker in Chiyoda-ku Tokyo, Japan, 19 510(k) clearances and 1 PMA approval
Fujita Co., Ltd. is registered with the FDA (registration 3036666444) in Chiyoda-ku Tokyo, Japan. It lists 12 device types. The FDA files 19 510(k) clearances and 1 PMA approval under its listings, the newest dated June 4, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3036666444
- Address
- 5-1-1 Koujimachi, Chiyoda-ku Tokyo, Japan, 1020083
- Owner or operator
- FUJITA CO., LTD. (10092556)
- Roles
- Exporter to the US
- First device listed
- January 28, 2025
- Registered through
- 2027
- Brand names listed
- GE 1.5T Signa HDXT MR, GE DPX Bravo Bone Densitometer, GE Discovery NM 830, GE Discovery PET/CT 690, GE Innova IGS Cath Angio, GE Lunar Prodigy Bone Densitometer, GE Signa Excite 1.5T, Hologic Dimensions 3D Mammography and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assembly, Tube Housing, X-Ray, Diagnostic | ITY | 1 | Exporter to the US | accessdata.fda.gov |
| Coil, Magnetic Resonance, Specialty | MOS | 2 | Exporter to the US | accessdata.fda.gov |
| Densitometer, Bone | KGI | 2 | Exporter to the US | accessdata.fda.gov |
| Digital Breast Tomosynthesis | OTE | 3 | 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, Fluoroscopic, Image-Intensified | JAA | 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 |
|---|---|---|---|---|---|---|
| June 4, 2019 | K190461 | Achieva 1.5T, 3.0T and Intera 1.5T MR Systems | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| April 4, 2018 | K173079 | Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | 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 |
| 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 |
| May 17, 2013 | K130885 | MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 1, 2013 | K130262 | MAGNETOM ESSENZA WITH SYNGO MR D14 | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | 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 |
| May 23, 2012 | K120579 | SOMATOM DEFINITION EDGE | JAK | Substantially Equivalent | Siemens Medical Systems, Inc. | accessdata.fda.gov |
| June 3, 2011 | K111445 | DISCOVERY NM 630 | KPS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| October 1, 2010 | K101347 | MAGNETOM AERA; MAGNETOM SKYRA | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 17, 2010 | K092564 | O-ARM IMAGING SYSTEM | OXO | Substantially Equivalent | Medtronic Navigation, Inc. (Littleton) | accessdata.fda.gov |
| June 18, 2009 | K090745 | ARTIS ZEE / ZEEGOS WITH SW VC14 | IZI | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 12, 2008 | K081496 | OPTIMA PET/CT 560 | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| June 17, 2004 | K041476 | GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| April 2, 2004 | K040665 | SOMATOM SENSATION 64 AND SENSATION CARDIAC | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 25, 2003 | K030962 | DPX SERIES BRAVO DUO BONE DENSITOMETER | KGI | Substantially Equivalent | Ge Lunar Corp. | accessdata.fda.gov |
| November 8, 2002 | K023398 | HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY | KGI | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| August 5, 1997 | K971684 | MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE) | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 11, 2011 | P080003 | SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | OTE | 10 | November 24, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of System, Tomography, Computed, Emission
- All makers of Digital Breast Tomosynthesis
- All makers of System, X-Ray, Angiographic
- All makers of Densitometer, Bone
- All makers of Assembly, Tube Housing, X-Ray, Diagnostic
Updated November 24, 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.