Data / Medical devices / South Korea / Vuno Inc.
Vuno Inc.: FDA-registered device maker in Seoul, South Korea, 2 510(k) clearances
Vuno Inc. is registered with the FDA (registration 3029915548) in Seoul, South Korea. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 15, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029915548
- Address
- 9F, 479, Gangnam-daero, Seocho-gu, Seoul, South Korea, 06541
- Owner or operator
- VUNO Inc. (10089077)
- Roles
- Manufacturer
- First device listed
- November 3, 2023
- Registered through
- 2026
- Brand names listed
- VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage, VUNO Med-DeepBrain
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Radiological Computer-Assisted Prioritization Software For Lesions | QFM | 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 15, 2024 | K241439 | VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage | QFM | Substantially Equivalent | Vuno, Inc. | accessdata.fda.gov |
| October 4, 2023 | K231398 | VUNO Med-DeepBrain | QIH | Substantially Equivalent | Vuno, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Automated Radiological Image Processing Software
- All makers of Radiological Computer-Assisted Prioritization Software For Lesions
Updated November 15, 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.