Medical device licence · 87775 · Class 2
SYNGO.INTERVENTIONAL
Yes: licensed in Canada
Licence status Issued (active); first licensed December 6, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 87775
- Licence holder
- Siemens Healthcare GmbhErlangen, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- December 6, 2011
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SYNGO.INTERVENTIONAL - CD
- SYNGO.INTERVENTIONAL 3D QUANTITATIVE (IZ3D)
- SYNGO.INTERVENTIONAL LEFT VENTRICULAR ANALYSIS (LVA)
- SYNGO.INTERVENTIONAL QCA BIFURCATION (QCA BIF)
- SYNGO.INTERVENTIONAL QUANTITATIVE CORONARY ANALYSIS (QCA)
- SYNGO.INTERVENTIONAL QUANTITATIVE VASCULAR ANALYSIS (QVA)
- SYNGO.INTERVENTIONAL VIEWER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.