Medical device licence · 18102 · Class 2
EDGE ECLIPSE MR IMAGING SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed March 3, 2000; ended September 22, 2009. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 18102
- Licence holder
- Philips Medical Systems Nederland B.V.Orange Village, OH, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- March 3, 2000
- Ended
- September 22, 2009
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 1.5T EDGE ECLIPSE SYSTEM - BODY COILS
- 1.5T EDGE ECLIPSE SYSTEM - BREAST BIOPSY COILS
- 1.5T EDGE ECLIPSE SYSTEM - ENDORECTAL PROBE
- 1.5T EDGE ECLIPSE SYSTEM - HEAD/NECK COILS
- 1.5T EDGE ECLIPSE SYSTEM - JOINT COILS
- 1.5T EDGE ECLIPSE SYSTEM - LOWER EXTREMITY COILS
- 1.5T EDGE ECLIPSE SYSTEM - MAIN UNIT
- 1.5T EDGE ECLIPSE SYSTEM - PERIPHERAL VASCULAR COILS
- 1.5T EDGE ECLIPSE SYSTEM - SHOULDER COILS
- 1.5T EDGE ECLIPSE SYSTEM - WRIST/HAND COILS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.