98 Spit Brook Road, Suite 100, Nashua, NH, United States, 03062
Showing 1–20 of 50 devices
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| AXXENT CERVICAL APPLICATOR | 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) |
| Axxent Electronic Brachytherapy System Model 110 XP 1200 | 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) |
| ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024 | 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) |
| ICAD VERALOOK CTC CAD SOFTWARE | 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) |
| IREVEAL BREAST DENSITY ASSESSMENT 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) |
| IREVEAL PORT LICENSE | 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) |
| M-VU ALGORITHM ENGINE | Registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| M-VU BREAST DENSITY | 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) |
| M-VU CAD STATION | 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) |
| M-VU DIGITIZE & ARCHIVE | 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) |
| M-VU VIEWER STATION | 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) |
| POWERLOOK ADVANCED MAMMOGRAPHY PLATFORM (AMP) SECONDLOOK DIGITAL SOFTWARE PORT LICENSES | 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) |
| POWERLOOK ADVANCED MAMMOGRAPHY PLATFORM (AMP) SECONDLOOK PREMIER SOFTWARE PORT LICENSES | 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) |
| POWERLOOK ADVANCED MAMMOGRAPHY PLATFORM (AMP) SYSTEM WITH SECONDLOOK DIGITAL | 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) |
| POWERLOOK ADVANCED MAMMOGRAPHY PLATFORM (AMP) SYSTEM WITH SECONDLOOK PREMIER | 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) |
| POWERLOOK AMP PRO WITH TOMOSYNTHESIS CONCURRENT CAD 1ST PORT | 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) |
| POWERLOOK AMP WITH IREVEAL | 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) |
| PowerLook® Density Assessment | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
| PowerLook Density Assessment Software | 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) |
| POWERLOOK DENSITY ASSESSMENT SOFTWARE V2.1 | 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) |
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