Medical device licence · 112287 · Class 2
GF85 DIAGNOSTIC X-RAY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 27, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 112287
- Licence holder
- Samsung Electronics Co., Ltd.Suwon-Si, GD, South Korea
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 27, 2024
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AUTO STITCHING STAND
- COLLIMATOR
- DIAGNOSTIC X-RAY SYSTEM
- DIGITAL FLAT PANEL X-RAY DETECTOR
- ROTATING ANODE X-RAY TUBE ASSEMBLY
- X-RAY HIGH VOLTAGE GENERATOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.