Level 7, 700 Swanston Street, Carlton, Australia, VIC 3053
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| CAC Software | Registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| CT LUNG DENSITY ANALYSIS (LDA) SOFTWARE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| CT LUNG TEXTURE ANALYSIS SOFTWARE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| CT Lung Ventilation Analysis Software (CT:V) | 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) |
| CT LVAS | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| CT:VQ | Registered with US (FDA) | Registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
Get alerts on new registrations, recalls, and regulatory changes.
