Medical device licence · 94330 · Class 2
ECHOINSIGHT
No longer licensed: suspended: invalid quality-system certificate
Licence status Suspended: invalid quality-system certificate; first licensed December 3, 2014; ended July 29, 2019. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 94330
- Licence holder
- Epsilon Imaging, Inc.Ann Arbor, MI, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- December 3, 2014
- Ended
- July 29, 2019
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ECHOINSIGHT FOR CARDIO ONCOLOGY
- ECHOINSIGHT FOR RESEARCH
- ECHOINSIGHT FOR RIGHT VENTRICLE
- ECHOINSIGHT FOR STRESS ECHO
- ECHOINSIGHT SUITE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.