Medical device licence · 26577 · Class 3
INSTATRAK 3500 PLUS SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed January 3, 2001; ended February 20, 2019. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 26577
- Licence holder
- Ge Oec Medical Systems Inc.Salt Lake City, UT, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 3, 2001
- Ended
- February 20, 2019
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- INSTATRAK 3500 PLUS SYSTEM
- INSTATRAK 3500 PLUS SYSTEM - IMAGE FUSION APPLICATION PLUS KIT
- INSTATRAK 3500 PLUS SYSTEM - MAIN UNIT
- INSTATRAK 3500 PLUS SYSTEM - NAVIGATION SENSOR CABLES
- INSTATRAK 3500 PLUS SYSTEM - SOFTWARE
- INSTATRAK 3500 PLUS SYSTEM - SOFTWARE APPLICATIONS
- INSTATRAK 3500 PLUS SYSTEM - SOFTWARE VERSION 5.2
- INSTATRAK 3500 PLUS SYSTEM - SOFTWARE VERSION 5.2.1
- INSTATRAK 3500 PLUS SYSTEM - UPGRADE KITS
- INSTATRAK 3500 PLUS SYSTEM - V 5.2 UPGRADE KIT
- INSTATRAK 3500 PLUS SYSTEM - V 5.2.1 UPGRADE KIT
- INSTATRAK 3500 SYSTEM
- INSTATRAK 3500 SYSTEM - IMAGE FUSION APPLICATION PLUS KIT
- INSTATRAK 3500 SYSTEM - INSTATRAK 3500 PLUS, V 5.2 UPGRADE KIT
- INSTATRAK 3500 SYSTEM - SOFTWARE VERSION 5.2
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 “instatrak”. A notice may cover another product or only some lots: read it to see what it covers.
- Instatrak 3500 Plus SystemDecember 24, 2012 · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.