Medical device licence · 16336 · Class 3
INTEGRIS CARDIOLOGY IMAGING SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 24, 2000. It is in Health Canada’s list of active licences.
- Licence number
- 16336
- Licence holder
- Philips Medical Systems Nederland B.V.Orange Village, OH, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- January 24, 2000
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- INTEGRIS ALLURA 9C
- INTEGRIS BH5000 CARDIOLOGY IMAGING SYSTEM
- INTEGRIS H5000C CATDIOLOGY IMAGING SYSTEM
- INTEGRIS H5000F CARDIOLOGY IMAGING SYSTEM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.