4-8 F, 374, Gangnam-daero, Gangnam-gu, Seoul, South Korea, 06241
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| Lunit INSIGHT CXR | Not registered with US (FDA) | Registered with UK (MHRA) | Registered with Canada (Health Canada) | Registered with AU (TGA) | Registered with EU (EUDAMED) |
| Lunit INSIGHT CXR Triage | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| Lunit INSIGHT DBT | Registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| Lunit INSIGHT DBT v1.1 | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| Lunit INSIGHT DBT (V1.2) | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| Lunit INSIGHT MMG | Registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Registered with AU (TGA) | Registered with EU (EUDAMED) |
| Lunit INSIGHT MMG, Lunit INSIGHT DBT | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| Lunit INSIGHT MMG (v1.1.10) | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
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