Medical device licence · 60752 · Class 2
DDRCHEST-SYSTEM
No longer licensed: cancelled: quality-system requirement (2003)
Licence status Cancelled: quality-system requirement (2003); first licensed October 21, 2002; ended February 16, 2004. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 60752
- Licence holder
- Swissray Medical AgHochdorf, LU, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 21, 2002
- Ended
- February 16, 2004
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DDRCHEST SYSTEM ACQUISITION STATION
- DDRCHEST SYSTEM BUCKY
- DDRCHEST SYSTEM EXPERT 4000 GENERATOR
- DDRCHEST SYSTEM EXTERNAL COLLIMATOR FILTER
- DDRCHEST SYSTEM MAIN UNIT
- DDRCHEST SYSTEM OPTICS MODULE
- DDRCHEST SYSTEM X-RAY TABLE
- DDRCHEST SYSTEM X-RAY TUBE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.