Medical device licence · 76091 · Class 3
SOMATOM DEFINITION AS
Yes: licensed in Canada
Licence status Issued (active); first licensed January 24, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76091
- Licence holder
- Siemens Healthcare GmbhErlangen, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 24, 2008
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SOMARIS/7 SYNGO CT
- SOMATOM DEFINITION AS - CONTROLBOX
- SOMATOM DEFINITION AS - ENHANCED EXTENDED FOV
- SOMATOM DEFINITION AS - GANTRY
- SOMATOM DEFINITION AS - GENERATOR
- SOMATOM DEFINITION AS - MAIN UNIT
- SOMATOM DEFINITION AS - OPEN BORE
- SOMATOM DEFINITION AS - SCAN RADIO THERAPY PLANNING (RTP)
- SOMATOM DEFINITION AS - SOFTWARE PACKAGE SOMARIS/7 VERSION VA 20
- SOMATOM DEFINITION AS - SOFTWARE PACKAGE SOMARIS/7 VERSION VA 26
- SOMATOM DEFINITION AS - SOMARIS/7 VERSION VA40
- SOMATOM DEFINITION AS - SYNGO CT / SOMARIS 7
- SOMATOM DEFINITION AS - TUBE COLLIMATOR (BEAM LIMITING DEVICE)
- SOMATOM DEFINITION AS - TUBE COLLIMATOR OPEN
- SOMATOM DEFINITION AS - X-RAY TUBE HOUSING STRATON MX P
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.