Medical device licence · 114675 · Class 3
EXABLATE 4000
Yes: licensed in Canada
Licence status Issued (active); first licensed January 14, 2026. It is in Health Canada’s list of active licences.
- Licence number
- 114675
- Licence holder
- Insightec, Ltd.Tirat Carmel, Israel
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 14, 2026
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EXABLATE 4000 HEAD FRAME SET TYPE 1.1
- EXABLATE 4000 TYPE 1.1 ADAPTER PLATE
- EXABLATE 4000 TYPE 1.1 COOLING CABINET
- EXABLATE 4000 TYPE 1.1 EQUIPMENT CABINET
- EXABLATE 4000 TYPE 1.1 FRONT-END (FE) UNIT
- EXABLATE 4000 TYPE 1.1 HELMET SYSTEM (HS) TYPE 1.1 (MIDDLE FREQUENCY)*
- EXABLATE 4000 TYPE 1.1 STORAGE & TRANSFER CART (STC)
- EXABLATE 4000 TYPE 1.1 WORKSTATION
- EXABLATE NEURO PATIENT TREATMENT KIT
- EXABLATE OPERATOR CONSOLE
- TREATMENT ACCESSORIES SET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.