Medical device licence · 91830 · Class 3
EXABLATE 2100
Yes: licensed in Canada
Licence status Issued (active); first licensed August 15, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 91830
- Licence holder
- Insightec, Ltd.Tirat Carmel, Israel
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 15, 2013
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EXABLATE 2100 - CRADLE
- EXABLATE 2100 - EQUIPMENT (CPC) CABINET ASSY
- EXABLATE 2100 - MR COIL
- EXABLATE 2100 - OPERATOR STATION ASSEMBLY
- EXABLATE 2100 - OPERATORS CONSOLE
- EXABLATE 2100 - TABLE ASSEMBLY
- EXABLATE 2100V1 TYPE 3.0 CRADLE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.