Medical device licence · 97645 · Class 2
DIRECTVIEW PC SOFTWARE APPLICATION
Yes: licensed in Canada
Licence status Issued (active); first licensed September 1, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97645
- Licence holder
- Respironics Inc.Murrysville, PA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- September 1, 2016
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DIRECTVIEW SOFTWARE PACKAGE, VERSION 2.4
- DIRECTVIEW SOFTWARE, WEB, VERSION 2.4
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “directview”. A notice may cover another product or only some lots: read it to see what it covers.
- Kodak DirectView DR 7500 System (2018-10-28)November 15, 2018 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.