Medical device licence · 62954 · Class 3
OMNIDIAGNOST ELEVA
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed September 11, 2003; ended October 3, 2011. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 62954
- Licence holder
- Philips Medical Systems Nederland B.V.Orange Village, OH, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 11, 2003
- Ended
- October 3, 2011
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OMNIDIAGNOST ELEVA
- OMNIDIAGNOST ELEVA - DIGITAL IMAGING
- OMNIDIAGNOST ELEVA - GENERATOR
- OMNIDIAGNOST ELEVA - SOFTWARE
- OMNIDIAGNOST ELEVA - SUBTRACTED ACQUISITION
- OMNIDIAGNOST ELEVA - X RAY TUBE
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 “omnidiagnost”. A notice may cover another product or only some lots: read it to see what it covers.
- MultiDiagnost-ELEVA, OmniDiagnost Systems (2019-03-03)March 15, 2019 · Medical devices · Medical devices · Type II
- Philips OmniDiagnost and OmniDiagnost Eleva (2018-05-07)May 18, 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.