Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3036666444

FEI Number

3036666444

Entity Name

FUJITA CO., LTD.

City/State/Country

Chiyoda-ku Tokyo, JP

Establishment Address

5-1-1 Koujimachi, Chiyoda-ku Tokyo 1020083, JP

Establishment Type(s)

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

Owner / Operator

FUJITA CO., LTD. (Owner Number: 10092556)

Owner / Operator Contact Address

5-1-1 Koujimachi, Chiyoda-ku, JP-13 1020083, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K023398

PMA Number

N/A

All Registered Proprietary Names

Siemens Somatom Definition Edge Philips Allura XPER FD20/10 Philips Allura XPER FD20 Philips Allura XPER FD20/15 Philips Allura XPER FD20/20 GE Discovery NM 830 GE Lunar Prodigy Bone Densitometer Hologic Dimensions 3D Mammography GE DPX Bravo Bone Densitometer GE Innova IGS Cath Angio GE Discovery PET/CT 690 GE 1.5T Signa HDXT MR Siemens Magnetom Aera MRI Medtronic O-Arm Siemens Somatom Sensation CT Siemens Biograph 16 TruePoint PET/CT Hologic Horizon Bone Densitometer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-09-04
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2025-04-28
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2025-04-28
KGI	Densitometer, Bone	Radiology	Class 2	892.1170	2025-02-03
OTE	Digital Breast Tomosynthesis	Unknown	Class 3	N/A	2026-06-10
KGI	Densitometer, Bone	Radiology	Class 2	892.1170	2025-02-03
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2025-03-12
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2025-03-12
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-03-12
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2025-12-30
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2025-02-16
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2025-02-16
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-02-16
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2026-04-07
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2025-02-16
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-06-02
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-01-21
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2026-01-21
KGI	Densitometer, Bone	Radiology	Class 2	892.1170	2026-06-10

Official Correspondent

Tetsuya Hara

US Agent Details

Grace Lyon Email: grace.lyon@blockimaging.com Phone: (517) 9997053

Related Public Records

Same Entity

FUJITA 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
K243523	Siemens Medical Solutions USA, Inc.	NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime	2025-02-12
K781431	General Electric Co.	ELECTRIC CT/T OPERATOR DISPLAY CONSOLE	1978-09-07
K231574	FUJIFILM Healthcare Americas Corporation	Scenaria View 4.2	2023-10-12
K233583	FUJIFILM Healthcare Americas Corporation	FCT iSTREAM Phase 1	2024-04-26
K151376	Covidien, LLC	superDimension Navigation System	2015-11-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2011	GE Medical Systems, LLC	2	HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017	Philips Medical Systems	2	Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017	Philips Medical Systems	2	Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017	Philips Medical Systems	2	Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017	Philips Medical Systems	2	Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Similar Registrations

Registration Number	Establishment Name	Location
3011825597	FAIR MEDICAL CO.,LTD	Kashiwa Chiba, JP
3007233544	VIDA DIAGNOSTICS	Coralville, IA, US
9614698	CANON INC.	OTAWARA-SHI Tochigi, JP
3010281549	J. MORITA MFG. CORP., TOTTORI FACTORY	Kurayoshi Tottori, JP
2134213	CANON MEDICAL INFORMATICS, INC.	MINNETONKA, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3036666444. Last updated year: 2026. Please use registration number 3036666444 when referencing this establishment in official correspondence.