Medical device licence · 65314 · Class 3
LEKSELL STEREOTACTIC SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 4, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 65314
- Licence holder
- Elekta Solutions AbStockholm, Sweden
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 4, 2004
- Devices covered
- 36
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- LEKSELL STEREOSTATIC SYSTEM - SALCMAN TWIST DRILL
- LEKSELL STEREOTACTIC SYSTEM - ADJUSTABLE MICROMETRIC STOP
- LEKSELL STEREOTACTIC SYSTEM - BACKLUND BIOPSY KITS
- LEKSELL STEREOTACTIC SYSTEM - BACKLUND CATHETER INSERTION NEEDLE
- LEKSELL STEREOTACTIC SYSTEM - BACKLUND HAEMATOMA EVACUATOR KIT
- LEKSELL STEREOTACTIC SYSTEM - BIOPSY KITS
- LEKSELL STEREOTACTIC SYSTEM - CLAMP
- LEKSELL STEREOTACTIC SYSTEM - COORDINATE FRAME MODEL G
- LEKSELL STEREOTACTIC SYSTEM - CROSS HAIR KITS
- LEKSELL STEREOTACTIC SYSTEM - ENDOSCOPE ADAPTER
- LEKSELL STEREOTACTIC SYSTEM - FIXATION POSTS
- LEKSELL STEREOTACTIC SYSTEM - IMPLANTATION SET
- LEKSELL STEREOTACTIC SYSTEM - INJECTION/ASPIRATION NEEDLE KIT
- LEKSELL STEREOTACTIC SYSTEM - INSERTION CANNULA KIT
- LEKSELL STEREOTACTIC SYSTEM - LUNSFORD GUIDEHOLDLER FOR COORD FRAME G
- LEKSELL STEREOTACTIC SYSTEM - MICRODRIVE
- LEKSELL STEREOTACTIC SYSTEM - MULTI PURPOSE STEREOTATCTIC ARC
- LEKSELL STEREOTACTIC SYSTEM - SEDAN SIDE-CUTTING BIOPSY NEEDLE
- LEKSELL STEREOTACTIC SYSTEM - SLOTTED FRONT PIECE
- LEKSELL STEREOTACTIC SYSTEM - STEINER LINDQUIST MICROSURGICAL LASER GUIDE
- LEKSELL STEREOTACTIC SYSTEM - STOP/GUIDE
- LEKSELL STEREOTACTICS SYSTEM - ADJUSTABLE CT-ADAPTER
- LEKSELL STEREOTACTICS SYSTEM - CT-INDICATOR
- LEKSELL STEREOTACTICS SYSTEM - CT-SCALE
- LEKSELL STEREOTACTICS SYSTEM - FIXATION SCREWS
- LEKSELL STEREOTACTICS SYSTEM - FLAT X-RAY TABLE FIXATION
- LEKSELL STEREOTACTICS SYSTEM - LEKSELL MR PHANTOM
- LEKSELL STEREOTACTICS SYSTEM - LOCALIZATION RULER
- LEKSELL STEREOTACTICS SYSTEM - MR SCALE
- LEKSELL STEREOTACTICS SYSTEM - MR-INDICATOR
- LEKSELL STEREOTACTICS SYSTEM - SLIDES
- LEKSELL STEREOTACTICS SYSTEM - UNIVERSAL BOARD MR-ADAPTER
- LEKSELL STEREOTACTICS SYSTEM - UNIVERSAL CT-TABLE FIXATION
- LEKSELL STEREOTACTICS SYSTEM - UPGRADE KIT FOR STANDARD STEREROTACTIC ARC
- LEKSELL STEREOTACTICS SYSTEM - X-RAY CASSETTE HOLDER
- LEKSELL STEREOTACTICS SYSTEM - X-RAY INDICATOR
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “leksell”. A notice may cover another product or only some lots: read it to see what it covers.
- Leksell Gamma KnivesFebruary 18, 2026 · Radiology · Performance · Type II
- Leksell GammaPlan®December 23, 2025 · Radiology · Performance · Type II
- LEKSELL GAMMA KNIFE PERFEXION (2016-04-18)April 22, 2016 · Medical devices · Medical devices · Type II
- Leksell Gamma Knife Perfexion (2014-10-06)October 10, 2014 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.