Data / Medical devices / Transducer, Ultrasonic, Diagnostic / South Korea
FDA-registered makers of Transducer, Ultrasonic, Diagnostic in South Korea: 13 establishments
13 establishments in South Korea are registered with the FDA to make Transducer, Ultrasonic, Diagnostic (product code ITX). 3 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Transducer, Ultrasonic, Diagnostic
- Product code
- ITX
- Country
- South Korea
Makers of Transducer, Ultrasonic, Diagnostic 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 | 2 | January 5, 2011 | 0 | 0 | 0 | api.fda.gov |
| Samsung Medison Co., Ltd. | HONGCHEON-GUN Gangwon, South Korea | Manufacturer | 2 | January 5, 2011 | 0 | 0 | 0 | api.fda.gov |
| Mcube Technology Co., Ltd. | Seoul, South Korea | Manufacturer | 1 | April 27, 2011 | 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 | |
| ALPINION MEDICAL SYSTEMS Co., Ltd. | Gangseo-gu Seoul, South Korea | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bionet Co., Ltd. | Anyang-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edgecare Inc. | Yeongdeungpo-gu Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fcu Co., Ltd. | Daejeon, South Korea | Contract manufacturer, 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 | |
| Healcerion Co., Ltd | Seoul, 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 | |
| Siemens Healthineers Ltd. | SEONGNAM-SI Gyeonggi, South Korea | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthineers Ltd. | Pohang-si Gyeongbuk, South Korea | Manufacturer, Specification developer | 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.