SUMITOMO MITSUI FINANCE AND LEASING CO., LTD.

FDA Device Registration & Listing · TOKYO, JP · Registration 3012939903

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012939903
FEI Number
3012939903
Entity Name
SUMITOMO MITSUI FINANCE AND LEASING CO., LTD.
City/State/Country
TOKYO, JP
Establishment Address
1-3-2, MARUNOUCHI,, CHIYODA-KU,, TOKYO 100-8287, JP
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
SUMITOMO MITSUI FINANCE AND LEASING CO., LTD. (Owner Number: 10061600)
Owner / Operator Contact Address
2-1-1, HITOTSUBASHI, CHIYODA-KU,, TOKYO, JP-13 100-8287, JP
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K101874
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

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 2024-09-30
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-04-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-04-03
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-04-03
OTE Digital Breast Tomosynthesis Unknown Class 3 N/A 2022-01-19
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2020-11-13
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-04-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-04-03
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-04-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-04-03
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-04-03
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-04-03
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2020-11-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-04-03
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-04-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-04-03
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2020-11-19
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2020-11-19
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2020-11-19
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-04-03
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-04-03
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-04-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-04-03
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-04-03
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-04-03
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2021-07-08
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2021-04-23
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2021-04-23
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-04-03
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-04-03
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-04-03

Official Correspondent

KOJI HARADA

US Agent Details

SHOTA KAWASHIMA Business: SUMITOMO MITSUI FINANCE AND LEASING CO., LTD., NY BRANCH Email: SMBCSMFLEXPATS@smflus.com Phone: (917) 5423500

Related Public Records

Same Entity

SUMITOMO MITSUI FINANCE AND LEASING 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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012939903. Last updated year: 2026. Please use registration number 3012939903 when referencing this establishment in official correspondence.
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