Medical device licence · 71872 · Class 3
GEMINI TF 16 PET/CT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 14, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 71872
- Licence holder
- Philips Medical Systems Nederland B.V.Orange Village, OH, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 14, 2006
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GEMINI TF 16 PET/CT SYSTEM - BRILLIANCE CT SUBSYSTEM
- GEMINI TF 16 PET/CT SYSTEM - GEMINI SEPARATION UNIT
- GEMINI TF 16 PET/CT SYSTEM - GEMINI TF PET SUBSYSTEM
- GEMINI TF 16 PET/CT SYSTEM - MAIN UNIT
- GEMINI TF 16 PET/CT SYSTEM - PATIENT TABLE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.