Medical device licence · 104710 · Class 4
ACIST HDI SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 4, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104710
- Licence holder
- Acist Medical Systems Inc.Eden Prairie, MN, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- June 4, 2020
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACIST HDI LINEAR TRANSLATION SYSTEM (LTS)
- ACIST HDI PATIENT INTERFACE MODULE (PIM)
- ACIST HDI POWER SUPPLY
- ACIST HDI SYSTEM (SYSTEM CONSOLE, LINEAR TRANSLATIONS (LTS), PATIENT INTERFACE MODULE (PIM), POWER SUPPLY)
- ACIST HDI SYSTEM CONSOLE
- ACIST KODAMA CATHETER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.