Data / Medical devices / System, Imaging, Pulsed Doppler, Ultrasonic / Japan
FDA-registered makers of System, Imaging, Pulsed Doppler, Ultrasonic in Japan: 16 establishments
16 establishments in Japan are registered with the FDA to make System, Imaging, Pulsed Doppler, Ultrasonic (product code IYN). 12 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- System, Imaging, Pulsed Doppler, Ultrasonic
- Product code
- IYN
- Country
- Japan
Makers of System, Imaging, Pulsed Doppler, Ultrasonic in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| GE Healthcare Japan Corporation | HINO-SHI Tokyo, Japan | Manufacturer, Specification developer | 105 | October 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Canon Inc. | OTAWARA-SHI Tochigi, Japan | Contract manufacturer, Manufacturer | 40 | January 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| Canon Inc. | OHTA-KU Tokyo, Japan | Specification developer | 40 | January 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Corporation Medical Systems Research & Development Center Kokubunji | KOKUBUNJI-SHI Tokyo, Japan | Manufacturer | 19 | November 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office | Kashiwa-shi Chiba, Japan | Manufacturer | 19 | November 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| Konica Minolta Technoproducts Co., Ltd. | SAYAMA-SHI Saitama, Japan | Manufacturer | 7 | June 23, 2022 | 0 | 0 | 0 | api.fda.gov |
| Konica Minolta, Inc. | HINO-SHI Tokyo, Japan | Specification developer | 7 | June 23, 2022 | 0 | 0 | 0 | api.fda.gov |
| Olympus Medical Systems Corp. | HACHIOJI-SHI Tokyo, Japan | Specification developer | 5 | January 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Shirakawa Olympus Co., Ltd. | NISHISHIRAKAWA-GUN Fukushima, Japan | Manufacturer | 5 | January 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Fukuda Denshi Finetech Sendai Co., Ltd. | Kurokawa-gun Miyagi, Japan | Manufacturer | 4 | September 30, 2008 | 0 | 0 | 0 | api.fda.gov |
| Aizu Olympus Co., Ltd. | AIZUWAKAMATSU-SHI Fukushima, Japan | Manufacturer | 2 | June 17, 2010 | 0 | 0 | 0 | api.fda.gov |
| Fujifilm Corporation | ASHIGARAKAMI-GUN Kanagawa, Japan | Specification developer | 1 | March 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Corporation Medical Systems Research & Development Center Kaisei | Ashigarakami-Gun Kanagawa, Japan | Manufacturer | 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 | |
| Hadeco, Inc. | KAWASAKI Kanagawa, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant | NISHITAMA-GUN Tokyo, Japan | Manufacturer | 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.