ApprovalTrail

Medical device licence · 71990 · Class 3

SENOGRAPHE ESSENTIAL

Yes: licensed in Canada

Licence status Issued (active); first licensed July 31, 2006. It is in Health Canada’s list of active licences.
Licence number
71990
Licence holder
Ge Medical Systems ScsBuc, France
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
July 31, 2006
Devices covered
10

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • SENOGRAPHE ESSENTIAL - 2D BIOPSY LOCALISER
  • SENOGRAPHE ESSENTIAL - ECONTRAST
  • SENOGRAPHE ESSENTIAL - IMAGE RECEPTOR
  • SENOGRAPHE ESSENTIAL - KIT CORE SYSTEM UPGRADE STEREO ESSENTIAL
  • SENOGRAPHE ESSENTIAL - MAIN UNIT
  • SENOGRAPHE ESSENTIAL - MOBILE
  • SENOGRAPHE ESSENTIAL - QAP PIXEL MAPPING
  • SENOGRAPHE ESSENTIAL - SOFTWARE V. AWS 53.40
  • SENOGRAPHE ESSENTIAL - STEREOTAXY OPTION
  • SENOGRAPHE ESSENTIAL - STEREOTIX (POSITIONER)

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.