ApprovalTrail

Medical device licence · 78241 · Class 2

CARESTREAM DRX-1 SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed October 24, 2008. It is in Health Canada’s list of active licences.
Licence number
78241
Licence holder
Carestream Health, Inc.Rochester, NY, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Group Family
First licensed
October 24, 2008
Devices covered
18

Devices on this licence

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

  • CARESTREAM DRX TRANSPORTABLE DESKTOP BUNDLE
  • CARESTREAM DRX TRANSPORTABLE LITE DOCK
  • CARESTREAM DRX TRANSPORTABLE LITE DOCK, SERVICE
  • CARESTREAM DRX TRANSPORTABLE LITE MOUNT FOR MOTION MBLE
  • CARESTREAM DRX TRANSPORTABLE POWER BANK, SERVICE
  • CARESTREAM DRX TRANSPORTABLE SYSTEM UNIVERSAL MOBILE FOR DRX-1 & DRX
  • CARESTREAM DRX TRANSPORTABLE UNIVERSAL MOUNT
  • CARESTREAM DRX-1 SYSTEM, TETHERED
  • CARESTREAM DRX-1 SYSTEM, WIRELESS
  • CARESTREAM DRX-1 WIRELESS SYSTEM WITH DRX-1C DETECTOR
  • CARESTREAM DRX-MOBILE RETROFIT KIT / SHIMADZU
  • CARESTREAM DRX-MOBILE RETROFIT KIT SIEMENS MOBILETTE PLUS
  • CARESTREAM DRX-MOBILE RETROFIT KIT SIEMENS MOBILETTE XP
  • CARESTREAM DRX-MOBILEL RETROFIT KIT GE
  • CARESTREAM DRX-TRANSPORTABLE SYSTEM / FIELD PORTABLE
  • CARESTREAM DRX-TRANSPORTABLE SYSTEM / LITE
  • CARESTREAM DRX-TRANSPORTABLE SYSTEM / UNIVERSAL MOBILE
  • DRX-TRANSPORTABLE SYSTEM / FLEX

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