Data / Medical devices / Automated Radiological Image Processing Software / South Korea
FDA-registered makers of Automated Radiological Image Processing Software in South Korea: 17 establishments
17 establishments in South Korea are registered with the FDA to make Automated Radiological Image Processing Software (product code QIH). 11 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
- Automated Radiological Image Processing Software
- Product code
- QIH
- Country
- South Korea
Makers of Automated Radiological Image Processing Software in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Coreline Soft Co., Ltd. | Seoul, South Korea | Complaint file establishment, Manufacturer | 4 | March 19, 2025 | 0 | 0 | 0 | api.fda.gov |
| Neurophet, Inc. | Seoul, South Korea | Manufacturer | 4 | May 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| AIRS Medical Inc. | Seoul, South Korea | Complaint file establishment, Manufacturer | 3 | July 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ewoosoft Co., Ltd | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 2 | May 23, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ontact Health Co., Ltd. | Busan, South Korea | Manufacturer | 2 | November 27, 2024 | 0 | 0 | 0 | api.fda.gov |
| Claripi Inc. | Seoul, South Korea | Complaint file establishment, Exporter to the US, Manufacturer | 1 | September 10, 2021 | 0 | 0 | 0 | api.fda.gov |
| Hutom Inc. | Seoul, South Korea | Manufacturer | 1 | July 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| JLK, Inc. | Gangnam Seoul, South Korea | Manufacturer | 1 | June 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| MEDICAL IP Co., Ltd. | Seoul, South Korea | Manufacturer | 1 | June 16, 2023 | 0 | 0 | 0 | api.fda.gov |
| Medipixel, Inc. | Gangnam-gu Seoul, South Korea | Manufacturer | 1 | March 22, 2023 | 0 | 0 | 0 | api.fda.gov |
| Vuno Inc. | Seoul, South Korea | Manufacturer | 1 | October 4, 2023 | 0 | 0 | 0 | api.fda.gov |
| Edgecare Inc. | Yeongdeungpo-gu Seoul, 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 | |
| Samsung Medison Co., Ltd. | Gumi-si Gyeongbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Samsung Medison Co., Ltd. | HONGCHEON-GUN Gangwon, 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 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.