Medical device licence · 85607 · Class 2
PICTOR
Yes: licensed in Canada
Licence status Issued (active); first licensed March 24, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 85607
- Licence holder
- Volk Optical Inc.Mentor, OH, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- March 24, 2011
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PICTOR ANTERIOR MODULE
- PICTOR BATTERY
- PICTOR CRADLE
- PICTOR DERMATOSCOPIC MODULE
- PICTOR IMAGING HANDSET
- PICTOR INSUFFLATION BULB
- PICTOR OTOSCOPIC MODULE
- PICTOR PLUS ANTERIOR MODULE
- PICTOR PLUS IMAGING HANDSET
- PICTOR PLUS RETINA MODULE
- PICTOR RETINA MODULE
- PICTOR SILICONE EYE CUP
- PICTOR SKIN CONTACT GLASS
- PICTOR SPECULA
- VOLK PICTOR PLUS FLUORESCEIN ANGIOGRAPHY (FA) MODULE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.