Medical device licence · 102456 · Class 3
ALPHENIX INFX-8000C
Yes: licensed in Canada
Licence status Issued (active); first licensed February 25, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 102456
- Licence holder
- Canon Inc.Tokyo, Japan
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 25, 2019
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALPHENIX INFX-8000C - MAIN UNIT
- ALPHENIX INFX-8000C - SOFTWARE
- ALPHENIX INFX-8000C - UPGRADE KITS
- DLS UPGRADE KIT
- INTERVENTIONAL ANGIOGRAPHY SYSTEM ALPHENIX MODEL INFX-8000C
- SOFTWARE UPGRADE KIT
- SYSTEM SOFTWARE VERSION
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 “alphenix”. A notice may cover another product or only some lots: read it to see what it covers.
- Alphenix SystemsFebruary 10, 2026 · Radiology · Performance · Type II
- Infinix and Alphenix Systen C-Arm Suspension and TableJune 21, 2024 · Radiology · Performance · Type II
- Alphenix INFX-8000v - Main UnitNovember 8, 2023 · Radiology · Performance · Type II
- Alphenix INFX-8000CMay 19, 2023 · Radiology · Performance · Type II
- Alphenix INFX-8000v Main UnitJuly 18, 2022 · Radiology · Performance · Type II
- INFINIX VC-I-SYSTEM & ALPHENIX INFX-8000C - MAIN UNIT (2020-09-11)September 25, 2020 · 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.