Medical device licence · 60077 · Class 2
NUCLINE X-RING/4R
No longer licensed: cancelled: quality-system requirement (2003)
Licence status Cancelled: quality-system requirement (2003); first licensed July 15, 2002; ended March 12, 2004. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 60077
- Licence holder
- Mediso:Medical Imaging SystemsBudapest, Hungary
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 15, 2002
- Ended
- March 12, 2004
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- NUCLINE X-RING-4R SYSTEM - COLLIMATORS
- NUCLINE X-RING-4R SYSTEM - ECG GATING DEVICE
- NUCLINE X-RING-4R SYSTEM - GAMMA CAMERA
- NUCLINE X-RING-4R SYSTEM - PEDAL SWITCH FOR ANATOMICAL MARKING
- NUCLINE X-RING-4R SYSTEM - PET OPTION
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.