Medical device licence · 106913 · Class 2
MYOSPECT
Yes: licensed in Canada
Licence status Issued (active); first licensed November 2, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106913
- Licence holder
- Ge Medical Systems Israel, Functional ImagingTirat Hacarmel, Israel
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 2, 2021
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MYOSPECT
- MYOSPECT ES
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 “myospect”. A notice may cover another product or only some lots: read it to see what it covers.
- MyoSPECT Molecular ImagingMay 7, 2024 · Radiology · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.