Data / Medical devices / Japan / Sumitomo Mitsui Finance And Leasing Co., Ltd.

Sumitomo Mitsui Finance And Leasing Co., Ltd.: FDA-registered device maker in Tokyo, Japan, 19 510(k) clearances and 1 PMA approval

Name: Sumitomo Mitsui Finance And Leasing Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sumitomo Mitsui Finance And Leasing Co., Ltd. is registered with the FDA (registration 3012939903) in 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 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012939903
Address: 1-3-2, Marunouchi, Chiyoda-Ku, Tokyo, Japan, 100-8287
Owner or operator: SUMITOMO MITSUI FINANCE AND LEASING CO., LTD. (10061600)
Roles: Exporter to the US
First device listed: December 3, 2019
Registered through: 2026
Brand names listed: Invenia ABUS

Devices it lists

Device	Product code	Class	Role	Source
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, Image Processing, Radiological	LLZ	2	Exporter to the US	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Exporter to the US	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	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, 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
Transducer, Ultrasonic, Diagnostic	ITX	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
May 4, 2018	K180641	Invenia ABUS Viewer	LLZ	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
February 12, 2014	K133533	LOGIQ E	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
September 11, 2012	K122387	VOLUSON P6, VOLUSON P8	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
April 27, 2012	K120741	VOLUSON S6, VOLUSON S8	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
September 1, 2011	K112213	VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
October 5, 2010	K101874	GE LOGIQ P6/P6 PRO	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
August 31, 2010	K101878	GE LOGIQ P5 MODEL H44662LD	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
October 8, 2008	K082816	GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM	JAK	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
October 8, 2008	K082761	GE LIGHTSPEED 7.2 CT SCANNER SYSTEM	JAK	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
December 18, 2007	K073297	GE LOGIQ P6	IYN	Substantially Equivalent	General Electric Co.	accessdata.fda.gov
July 12, 2006	K061817	LIGHTSPEED 7.1 CT SCANNER SYSTEM	JAK	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
July 12, 2006	K061682	GE VOLUSON E8 ULTRASOUND SYSTEM	IYO	Substantially Equivalent	General Electric Co.	accessdata.fda.gov
May 3, 2006	K060993	GE LOGIQ P5 AND A5	IYN	Substantially Equivalent	General Electric Co.	accessdata.fda.gov
September 8, 2004	K042293	BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER	JAK	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.	accessdata.fda.gov
July 30, 2004	K041949	ALLURA XPER FD10	IZI	Substantially Equivalent	Philips Medical Systems North America Co.	accessdata.fda.gov
December 9, 2003	K033737	ALLURA XPER FD20	OWB	Substantially Equivalent	Philips Medical Systems North America, Inc.	accessdata.fda.gov
August 22, 2003	K031637	INNOVA 3100	OWB	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov
April 17, 2002	K021049	OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM	OWB	Substantially Equivalent	Ge Oec Medical Systems	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

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.