Data / Medical devices / Transducer, Ultrasonic, Diagnostic / Japan

FDA-registered makers of Transducer, Ultrasonic, Diagnostic in Japan: 26 establishments

Name: FDA-registered makers of Transducer, Ultrasonic, Diagnostic in Japan
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

26 establishments in Japan are registered with the FDA to make Transducer, Ultrasonic, Diagnostic (product code ITX). 15 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.

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Device: Transducer, Ultrasonic, Diagnostic
Product code: ITX
Country: Japan

Makers of Transducer, Ultrasonic, Diagnostic in Japan

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Olympus Medical Systems Corp.	HACHIOJI-SHI Tokyo, Japan	Specification developer	6	September 18, 2025	0	api.fda.gov
Shirakawa Olympus Co., Ltd.	NISHISHIRAKAWA-GUN Fukushima, Japan	Manufacturer	5	September 18, 2025	0	api.fda.gov
Canon Inc.	OTAWARA-SHI Tochigi, Japan	Contract manufacturer, Manufacturer	4	February 2, 2011	0	api.fda.gov
Canon Inc.	OHTA-KU Tokyo, Japan	Specification developer	4	February 2, 2011	0	api.fda.gov
FUJIFILM Corporation Medical Systems Research & Development Center Kokubunji	KOKUBUNJI-SHI Tokyo, Japan	Manufacturer, Specification developer	4	August 12, 2026	0	api.fda.gov
OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant	NISHITAMA-GUN Tokyo, Japan	Manufacturer	4	May 26, 2000	0	api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office	Kashiwa-shi Chiba, Japan	Manufacturer	3	October 16, 2014	0	api.fda.gov
Fukuda Denshi Finetech Sendai Co., Ltd.	Kurokawa-gun Miyagi, Japan	Manufacturer	2	April 8, 2011	0	api.fda.gov
GE Healthcare Japan Corporation	HINO-SHI Tokyo, Japan	Manufacturer, Specification developer	2	October 5, 2012	0	api.fda.gov
Japan Gas Company Limited	YOKOHAMA Kanagawa, Japan	Manufacturer	2	October 16, 2014	0	api.fda.gov
FUJIFILM Corporation Medical Systems Research & Development Center Kaisei	Ashigarakami-Gun Kanagawa, Japan	Complaint file establishment, Manufacturer, Specification developer	1	December 13, 2023	0	api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Sano Office	Sano City Tochigi, Japan	Manufacturer	1	December 13, 2023	0	api.fda.gov
Hadeco, Inc.	KAWASAKI Kanagawa, Japan	Manufacturer	1	May 11, 1995	0	api.fda.gov
HOYA Corporation PENTAX Lifecare Division	KURIHARA-SHI Miyagi, Japan	Exporter to the US, Manufacturer	1	June 9, 2004	0	api.fda.gov
HOYA Corporation PENTAX Lifecare Division	Akishima-shi Tokyo, Japan	Complaint file establishment, Specification developer	1	June 9, 2004	0	api.fda.gov
Aizu Olympus Co., Ltd.	AIZUWAKAMATSU-SHI Fukushima, Japan	Manufacturer	0		1	api.fda.gov
AOMORI OLYMPUS CO., LTD. Kuroishi Site	KUROISHI-SHI Aomori, Japan	Manufacturer	0		0	api.fda.gov
Fujifilm Corporation	ASHIGARAKAMI-GUN Kanagawa, Japan	Specification developer	0		0	api.fda.gov
Konica Minolta Technoproducts Co., Ltd.	SAYAMA-SHI Saitama, Japan	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Konica Minolta, Inc.	HINO-SHI Tokyo, Japan	Specification developer	0		0	api.fda.gov
Nidek Co., Ltd.	Gamagori, Aichi, Japan	Specification developer	0		0	api.fda.gov
Nidek Co., Ltd. Hamacho Plant	Gamagori, Aichi, Japan	Manufacturer	0		0	api.fda.gov
Nihon Dempa Kogyo Co., Ltd.	Sayama-shi Saitama, Japan	Contract manufacturer	0		0	api.fda.gov
Tochigi Seiko Co., Ltd	Tochigi-shi, Japan	Contract manufacturer	0		0	api.fda.gov
Tochigichizuka Plant	Chizuka, Tochigi, Japan	Contract manufacturer	0		0	api.fda.gov
Ueda Japan Radio Co., Ltd.	Ueda-shi Nagano, Japan	Contract manufacturer	0		0	api.fda.gov

Updated November 2, 2026. 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.