Data / Medical devices / System, Imaging, Pulsed Echo, Ultrasonic / South Korea
FDA-registered makers of System, Imaging, Pulsed Echo, Ultrasonic in South Korea: 13 establishments
13 establishments in South Korea are registered with the FDA to make System, Imaging, Pulsed Echo, Ultrasonic (product code IYO). 9 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 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 Echo, Ultrasonic
- Product code
- IYO
- Country
- South Korea
Makers of System, Imaging, Pulsed Echo, Ultrasonic in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthineers Ltd. | Pohang-si Gyeongbuk, South Korea | Manufacturer, Specification developer | 8 | June 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Mcube Technology Co., Ltd. | Seoul, South Korea | Manufacturer | 5 | August 19, 2020 | 0 | 0 | 0 | api.fda.gov |
| Edgecare Inc. | Yeongdeungpo-gu Seoul, South Korea | Manufacturer | 2 | April 17, 2026 | 0 | 0 | 0 | api.fda.gov |
| Fcu Co., Ltd. | Daejeon, South Korea | Contract manufacturer, Manufacturer | 2 | June 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| ALPINION MEDICAL SYSTEMS Co., Ltd. | Gangseo-gu Seoul, South Korea | Complaint file establishment, Manufacturer, Specification developer | 1 | July 26, 2012 | 0 | 0 | 0 | api.fda.gov |
| Healcerion Co., Ltd | Seoul, South Korea | Manufacturer | 1 | September 10, 2015 | 0 | 0 | 0 | api.fda.gov |
| Samsung Medison Co., Ltd. | Gumi-si Gyeongbuk, South Korea | Manufacturer | 1 | August 20, 2013 | 0 | 0 | 0 | api.fda.gov |
| Samsung Medison Co., Ltd. | HONGCHEON-GUN Gangwon, South Korea | Manufacturer | 1 | August 20, 2013 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthineers Ltd. | SEONGNAM-SI Gyeonggi, South Korea | Specification developer | 1 | June 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Alpinion Medical Systems Co., Ltd. | Anyang-si Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bionet Co., Ltd. | Anyang-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Ultrasound Korea, Ltd. | Seongnam-Si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Humanscan Co., Ltd | Siheung-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.