Medical device licence · 92609 · Class 2
D-SPECT VISTA
Yes: licensed in Canada
Licence status Issued (active); first licensed January 16, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 92609
- Licence holder
- Spectrum Dynamics Medical Ltd.Caesarea, Israel
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- January 16, 2014
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- D-SPECT ACQUISITION STATION
- D-SPECT L CARDIAC SCANNER
- D-SPECT L PROCESSING STATION
- D-SPECT POWER UNIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.