Data / Medical devices / System, Imaging, Pulsed Echo, Ultrasonic / Japan
FDA-registered makers of System, Imaging, Pulsed Echo, Ultrasonic in Japan: 17 establishments
17 establishments in Japan are registered with the FDA to make System, Imaging, Pulsed Echo, Ultrasonic (product code IYO). 12 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- System, Imaging, Pulsed Echo, Ultrasonic
- Product code
- IYO
- Country
- Japan
Makers of System, Imaging, Pulsed Echo, Ultrasonic in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Canon Inc. | OTAWARA-SHI Tochigi, Japan | Contract manufacturer, Manufacturer | 3 | August 16, 2012 | 0 | 0 | 0 | api.fda.gov |
| Canon Inc. | OHTA-KU Tokyo, Japan | Specification developer | 3 | August 16, 2012 | 0 | 0 | 0 | api.fda.gov |
| Konica Minolta Technoproducts Co., Ltd. | SAYAMA-SHI Saitama, Japan | Contract manufacturer, Manufacturer | 3 | September 6, 2018 | 0 | 0 | 0 | api.fda.gov |
| Konica Minolta, Inc. | HINO-SHI Tokyo, Japan | Specification developer | 3 | September 6, 2018 | 0 | 0 | 0 | api.fda.gov |
| Fukuda Denshi Finetech Sendai Co., Ltd. | Kurokawa-gun Miyagi, Japan | Manufacturer | 2 | October 15, 1999 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Corporation Medical Systems Research & Development Center Kokubunji | KOKUBUNJI-SHI Tokyo, Japan | Manufacturer | 1 | November 20, 2009 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office | Kashiwa-shi Chiba, Japan | Manufacturer | 1 | November 20, 2009 | 0 | 0 | 0 | api.fda.gov |
| Hadeco, Inc. | KAWASAKI Kanagawa, Japan | Manufacturer | 1 | October 31, 1996 | 0 | 0 | 0 | api.fda.gov |
| Nidek Co., Ltd. | Gamagori, Aichi, Japan | Specification developer | 1 | May 3, 2002 | 0 | 0 | 0 | api.fda.gov |
| Nidek Co., Ltd. Hamacho Plant | Gamagori, Aichi, Japan | Manufacturer | 1 | May 3, 2002 | 0 | 0 | 0 | api.fda.gov |
| Olympus Medical Systems Corp. | HACHIOJI-SHI Tokyo, Japan | Specification developer | 1 | April 15, 1996 | 0 | 0 | 0 | api.fda.gov |
| Shirakawa Olympus Co., Ltd. | NISHISHIRAKAWA-GUN Fukushima, Japan | Manufacturer | 1 | April 15, 1996 | 0 | 0 | 0 | api.fda.gov |
| Aizu Olympus Co., Ltd. | AIZUWAKAMATSU-SHI Fukushima, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fujifilm Corporation | ASHIGARAKAMI-GUN Kanagawa, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Corporation Medical Systems Research & Development Center Kaisei | Ashigarakami-Gun Kanagawa, Japan | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Healthcare Manufacturing Corporation Sano Office | Sano City Tochigi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Healthcare Japan Corporation | HINO-SHI Tokyo, Japan | Manufacturer, Specification developer | 0 | 0 | 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.