Data / Medical devices / System, Imaging, Pulsed Doppler, Ultrasonic / South Korea
FDA-registered makers of System, Imaging, Pulsed Doppler, Ultrasonic in South Korea: 12 establishments
12 establishments in South Korea are registered with the FDA to make System, Imaging, Pulsed Doppler, Ultrasonic (product code IYN). 9 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 Doppler, Ultrasonic
- Product code
- IYN
- Country
- South Korea
Makers of System, Imaging, Pulsed Doppler, Ultrasonic in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Samsung Medison Co., Ltd. | Gumi-si Gyeongbuk, South Korea | Manufacturer | 71 | October 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| Samsung Medison Co., Ltd. | HONGCHEON-GUN Gangwon, South Korea | Manufacturer | 71 | October 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthineers Ltd. | Pohang-si Gyeongbuk, South Korea | Manufacturer, Specification developer | 55 | June 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ge Ultrasound Korea, Ltd. | Seongnam-Si Gyeonggi, South Korea | Manufacturer | 28 | January 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| Humanscan Co., Ltd | Siheung-si Gyeonggi, South Korea | Manufacturer | 20 | November 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| ALPINION MEDICAL SYSTEMS Co., Ltd. | Gangseo-gu Seoul, South Korea | Complaint file establishment, Manufacturer, Specification developer | 18 | April 17, 2023 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthineers Ltd. | SEONGNAM-SI Gyeonggi, South Korea | Specification developer | 16 | June 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| Healcerion Co., Ltd | Seoul, South Korea | Manufacturer | 2 | April 22, 2022 | 0 | 0 | 0 | api.fda.gov |
| Bionet Co., Ltd. | Anyang-si Gyeonggi, South Korea | Manufacturer | 1 | October 11, 2022 | 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 | |
| Fcu Co., Ltd. | Daejeon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mediana Co., Ltd. | Wonju-Si, Gangwon-do, South Korea | Contract 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.