Medical device licence · 96969 · Class 3
EXABLATE 4000
Yes: licensed in Canada
Licence status Issued (active); first licensed May 17, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 96969
- Licence holder
- Insightec, Ltd.Tirat Carmel, Israel
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 17, 2016
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EXABLATE 4000
- TC MRGFUS HEAD COIL FOR 1.5T
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.