Data / Medical devices / South Korea / Taeyoung Soft
Taeyoung Soft: FDA-registered device maker in Gwacheon-si Gyeonggi, South Korea, 1 510(k) clearance
Taeyoung Soft is registered with the FDA (registration 3036758981) in Gwacheon-si Gyeonggi, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 31, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3036758981
- Address
- Gwacheon-daero 7-gil, 65, B, #1504-1505, Gwacheon-si Gyeonggi, South Korea, 13840
- Owner or operator
- Tae Young Soft Co,.Ltd. (10092750)
- Roles
- Manufacturer
- First device listed
- February 14, 2025
- Registered through
- 2026
- Brand names listed
- ZeTTA PACS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| January 31, 2025 | K241694 | ZeTTA PACS | LLZ | Substantially Equivalent | Tae Young Soft Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 31, 2025. 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.