Medical device licence · 85733 · Class 3
I-SEED MODEL AGX100
Yes: licensed in Canada
Licence status Issued (active); first licensed April 7, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 85733
- Licence holder
- Theragenics CorporationBuford, GA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- April 7, 2011
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- I-SEED AGX100 (LOOSE SEEDS FOR) EYE
- I-SEED MODEL AGX100 - KNOWN ACTIVITY SEED
- I-SEED MODEL AGX100 - LOADED SHIELDED MAGAZINES IN TPS
- I-SEED MODEL AGX100 - LOADED VSM IN TPSII
- I-SEED MODEL AGX100 - LOOSE SEEDS IN A VIAL
- LOADED C20 IN TPSII
- LOADED C20 IN TPSII INDIVIDUAL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.