Medical device licence · 104887 · Class 3
X-CUBE 70
Yes: licensed in Canada
Licence status Issued (active); first licensed July 9, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104887
- Licence holder
- Alpinion Medical Systems Co., Ltd.Seoul, South Korea
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 9, 2020
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CONVEX ARRAY TRANSDUCER
- DOPPLER PENCIL TRANSDUCER
- ENDOCAVITY TRANSDUCER
- LINEAR ARRAY TRANSDUCER
- SECTOR PHASED TRANSDUCER
- X-CUBE 70 - MAIN UNIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.