Data / Medical devices / Japan / Fukuda Denshi Finetech Sendai Co., Ltd.

Fukuda Denshi Finetech Sendai Co., Ltd.: FDA-registered device maker in Kurokawa-gun Miyagi, Japan, 8 510(k) clearances

Name: Fukuda Denshi Finetech Sendai Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Fukuda Denshi Finetech Sendai Co., Ltd. is registered with the FDA (registration 3010663777) in Kurokawa-gun Miyagi, Japan. It lists 3 device types. The FDA files 8 510(k) clearances under its listings, the newest dated April 8, 2011. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3010663777
Address: 5, Technohills, Taiwacho, Kurokawa-gun Miyagi, Japan, 981-3629
Owner or operator: Fukuda Denshi Co., Ltd. (9028352)
Roles: Manufacturer
First device listed: January 16, 2008
Registered through: 2026
Brand names listed: FD DS-5000 Series Telemetry, FD UF-5800 Ultrasound, FD UF-750 3D Ultrasound, Fukuda Denshi UF-800 Series Ultrasound, Fukuda Denshi UF-Series Ultrasound, Fukuda Denshi US-750 XT Ultrasound, Fukuda Denshi UltraSound UF-760AG, Sigma 5000 Series Ultrasound

Devices it lists

Device	Product code	Class	Role	Source
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Manufacturer	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
April 8, 2011	K110920	UF-760AG	ITX	Substantially Equivalent	Fukuda Denshi Co., Ltd.	accessdata.fda.gov
September 30, 2008	K082656	MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT	IYN	Substantially Equivalent	Fukuda Denshi USA, Inc.	accessdata.fda.gov
September 9, 2008	K081919	UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM	ITX	Substantially Equivalent	Fukuda Denshi Co., Ltd.	accessdata.fda.gov
June 14, 2006	K061437	SIGMA 5000 SERIES, IMAGIC	IYN	Substantially Equivalent	Kontron Medical Systems Sas	accessdata.fda.gov
February 17, 2005	K050363	FUKUDA DENSHI MODEL UF-850XTD	IYN	Substantially Equivalent	Fukuda Denshi USA, Inc.	accessdata.fda.gov
October 31, 2003	K033209	FUKUDA DENSHI MODEL FF SONIC UF-750XT	IYN	Substantially Equivalent	Fukuda Denshi USA, Inc.	accessdata.fda.gov
October 15, 1999	K990401	FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNING SYSTEM WITH DOPPLER	IYO	Substantially Equivalent	Fukuda Denshi USA, Inc.	accessdata.fda.gov
August 30, 1993	K922208	FUKUDA DENSHI MODEL UF-4500	IYO	Substantially Equivalent	Fukuda Denshi USA, Inc.	accessdata.fda.gov

Compare with other makers

Updated April 8, 2011. 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.