3200 North Grandview Blvd, Waukesha, United States, 53188
Showing 1–20 of 907 devices
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| 0.7T SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| 1.0T SIGNA HORIZON LX MAGNETIC RESONANCE SYSTEM | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| 1.0T SIGNA HORIZON MAGNETIC RESONANCE SYSTEM | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| 1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL | 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) |
| 1.5T GE 6-Channel Phased Array Flex Coil | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| 1.5T GE 6-Channel Phased Array Flex Coil (1.5T 6 Channel Coil with DV Connector) | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| 1.5T GP Flex Coil | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| 1.5T HDxt Upgrade Kit | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| 1.5T INFINITY TWINSPEED MR SYSTEM | 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) |
| 1.5T OPTIMA MR430S | 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) |
| 1.5T SIGNA CV/I MAGNETIC RESONANCE SYSTEM | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| 1.5T SIGNA HDX MR SYS - 8 CHAN UPGRADE FOR PRE-EXCITE BRM SYS W/CXK4 MAGNET | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| 1.5T SIGNA HDX MR SYSTEM - 32 CHANNEL UPGRADE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| 1.5T SIGNA HDX MR SYSTEM - CHANNEL UPGRADE FOR FIXED SITE 4X/5X SYSTEMS | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| 1.5T SIGNA HDX MR SYSTEM - FUNCTIONAL MR APPLICATIONS SOFTWARE UPGRADE PKG | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| 1.5T SIGNA HDX MR SYSTEM - GENERAL APPLICATIONS SOFTWARE UPGRADE PACKAGE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| 1.5T SIGNA HDX MR SYSTEM - GENERAL SOFTWARE OPTIONS | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| 1.5T SIGNA HDX MR SYSTEM - HARDWARE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| 1.5T SIGNA HDX MR SYSTEM - MAIN UNIT | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| 1.5T SIGNA HDX MR SYSTEM - NEURO APPLICATIONS SOFTWARE UPGRADE PACKAGE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
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