Medical device licence · 101914 · Class 2
ZEOS CAMERA SYSTEM, 4K
Yes: licensed in Canada
Licence status Issued (active); first licensed October 22, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101914
- Licence holder
- Santa Barbara Imaging SystemsGoleta, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 22, 2018
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CONTROL UNIT WITH IMAGE CAPTURE AND LIGHT ENGINE
- ZEOS 4K HDR SYSTEM, TABLET
- ZEOS 4K HDR SYSTEM, TABLET, TETHERED
- ZEOS 4K HDR, INTEGRATED CAMERA CONTROL UNIT AND MONITOR
- ZEOS 4K HDR, SINGLE USE CAMERA
- ZEOS 4K HDR, SINGLE USE CAMERA WITH SHEATH KIT
- ZEOS 4K UHD CAMERA CONTROL UNIT
- ZEOS 4K UHD CAMERA HEAD, C-MOUNT
- ZEOS 4K UHD CAMERA HEAD, INTEGRATED
- ZEOS SINGLE USE SHEATH KIT
- ZEOS TABLET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.