Data / Medical devices / South Korea / Ontact Health Co., Ltd.
Ontact Health Co., Ltd.: FDA-registered device maker in Busan, South Korea, 2 510(k) clearances
Ontact Health Co., Ltd. is registered with the FDA (registration 3044776706) in Busan, South Korea. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 27, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3044776706
- Address
- 184, Jungang-daero, Dong-gu, Busan, South Korea, 48821
- Owner or operator
- ONTACT HEALTH Co., Ltd. (10095526)
- Roles
- Manufacturer
- First device listed
- March 24, 2026
- Registered through
- 2026
- Brand names listed
- Sonix Health
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 27, 2024 | K240645 | Sonix Health | QIH | Substantially Equivalent | Ontact Health Co., Ltd. | accessdata.fda.gov |
| October 20, 2023 | K230209 | Sonix Health | QIH | Substantially Equivalent | Ontact Health Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Automated Radiological Image Processing Software
Updated November 27, 2024. 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.