Shanghai United Imaging Intelligence Co., Ltd.

11 devices* 12 registrations
✕ UK (MHRA) ✕ Canada (Health Canada)
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Devices

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Device Name US UK CA AU EU
Chest CT Computer Aided Diagnostic Software Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
CT Computer-Aided Triage Software Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
CT Image Analysis Software Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
Mammo Image Analysis Software Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
MRI Image Analysis Software Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
PET/CT Computer-Aided Diagnostic Software Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
PET/CT Image Analysis Software Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
uAI Easy Triage ICH 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)
uAI EasyTriage-Rib 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)
uAI Portal 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)
uMR 680 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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