Seoul, KR · 10 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | Class II | Radiology | 4 | 2025-03-19 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 3 | 2020-10-16 |
| OEB | — | — | — | 2 | 2025-12-03 |
| QKB | Radiological Image Processing Software For Radiation Therapy | Class II | Radiology | 1 | 2022-11-10 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-12-03 | K251203 | AVIEW Lung Nodule CAD | OEB | — | — |
| 2025-03-19 | K243689 | AVIEW | QIH | Class II | Radiology |
| 2025-02-14 | K243696 | AVIEW CAC | QIH | Class II | Radiology |
| 2024-03-29 | K233211 | AVIEW CAC | QIH | Class II | Radiology |
| 2023-02-24 | K221592 | AVIEW Lung Nodule CAD | OEB | — | — |
| 2022-12-23 | K214036 | AVIEW | QIH | Class II | Radiology |
| 2022-11-10 | K220408 | AVIEW RT ACS | QKB | Class II | Radiology |
| 2020-10-16 | K201710 | A View LCS | LLZ | Class II | Radiology |
| 2020-08-26 | K200714 | AVIEW | LLZ | Class II | Radiology |
| 2020-05-05 | K193220 | AVIEW LCS | LLZ | Class II | Radiology |