89 High Street, Hadleigh, Ipswich, Suffolk, IP7 5EA
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| Precision AI Surgical Planning System (PAI-SPS) | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
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