Medical device licence · 103423 · Class 3
EXABLATE 4000
Yes: licensed in Canada
Licence status Issued (active); first licensed August 7, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103423
- Licence holder
- Insightec, Ltd.Tirat Carmel, Israel
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 7, 2019
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADAPTER PLATE
- COOLING CABINET
- EXABLATE 4000 EQUIPMENT CABINET
- EXABLATE 4000 OPERATOR STATION ASSY
- EXABLATE HEAD COIL
- HELMET SYSTEM (HS) TYPE 1.1 (MIDDLE FREQUENCY)
- OPERATOR CONSOLE
- STORAGE & TRANSFER CART (STC)
- WORK STATION
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.