Medical device licence · 106456 · Class 3
ACESSA PROVU SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 28, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106456
- Licence holder
- Hologic, Inc.Sunnyvale, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 28, 2021
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACESSA PRO VU HANDPIECE
- ACESSA PRO VU HANDPIECE CABLE
- ACESSA PRO VU TRANSDUCER WITH SENSOR
- ACESSA PROVU CONSOLE
- ACESSA PROVU PAD CABLE
- ACESSA PROVU PADS
- ACESSA PROVU TABLE TOP FIELD GENERATOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.