Medical device licence · 101870 · Class 3
3DIMENSIONS MAMMOGRAPHY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 10, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101870
- Licence holder
- Hologic, Inc.Sunnyvale, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 10, 2018
- Devices covered
- 17
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 3DQUORUM
- CLARITY-HD
- FRAMELESS PADDLE
- I-VIEW
- INTELLIGENT 2D
- MAGNIFICATION PADDLE
- PERFORATED LOCALIZATION PADDLE
- RECTANGULAR LOCALIZATION MAGNIFICATION PADDLE
- RECTANGULAR OPENING LOCALIZATION PADDLE
- SMALL BREAST PADDLE
- SMARTCURVE PADDLE
- SPOT CONTACT PADDLE
- SPOT MAGNIFICATION PADDLE
- SYSTEM
- ULTRASOUND PADDLE
- UNIVERSAL WORKING STATION
- X-RAY DETECTOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.