Medical device licence · 101760 · Class 2
PIXA CAMERA SYSTEM, 4K
Yes: licensed in Canada
Licence status Issued (active); first licensed September 19, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101760
- Licence holder
- Santa Barbara Imaging SystemsGoleta, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- September 19, 2018
- Devices covered
- 16
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CAMERA CONTROL UNIT, PIXA CONSOLE 4K
- CAMERA HEAD, PIXA C-MOUNT
- CAMERA HEAD, PIXA INTEGRATED 4K
- PIXA 4K HDR SYSTEM CONTROL UNIT WITH IMAGE CAPTURE AND LIGHT ENGINE
- PIXA 4K HDR SYSTEM, CAMERA CONTROL UNIT WITH INTEGRATED DISPLAY
- PIXA 4K HDR SYSTEM, CAMERA HEAD, C-MOUNT
- PIXA 4K HDR SYSTEM, CAMERA HEAD, INTEGRATED
- PIXA 4K HDR SYSTEM, CAMERA KIT, SINGLE USE, CONICAL TIP, 2 ROTATING STOPCOCKS
- PIXA 4K HDR SYSTEM, CAMERA KIT, SINGLE USE, SHARP TIP, 2 ROTATING STOPCOCKS
- PIXA 4K HDR SYSTEM, CAMERA, SINGLE USE
- PIXA 4K HDR SYSTEM, SHEATH KIT, SINGLE USE, CONICAL TIP, 2 ROTATING STOPCOCKS
- PIXA 4K HDR SYSTEM, SHEATH KIT, SINGLE USE, SHARP TIP, 2 ROTATING STOPCOCKS
- PIXA 4K HDR SYSTEM, TABLET
- PIXA 4K HDR SYSTEM, TABLET, TETHERED
- PIXA 4K UHD CAMERA HEAD, C-MOUNT, 1CMOS
- PIXA 4K UHD CAMERA HEAD, INTEGRATED, 1CMOS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.