Medical device licence · 94696 · Class 3
INGENUITY FLEX
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed February 13, 2015; ended October 8, 2019. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 94696
- Licence holder
- Philips Medical Systems Nederland B.V.Orange Village, OH, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 13, 2015
- Ended
- October 8, 2019
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COLLIMATOR
- INGENUITY FLEX CT SYSTEM
- INGENUITY FLEX-GANTRY
- INGENUITY FLEX-OPERATOR CONSOLE
- INGENUITY FLEX-X RAY TUBE
- SOFTWARE
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “ingenuity”. A notice may cover another product or only some lots: read it to see what it covers.
- Philips CT System (Ingenuity, Iqon Spectral, Brilliance) (2021-05-07)May 20, 2021 · Medical devices · Medical devices · Type II
- Brilliance 40/64 Slice and Ingenuity CT Systems (2017-09-12)September 26, 2017 · Medical devices · Medical devices · Type II
- Brilliance and Ingenuity CT Systems (2016-11-18)December 5, 2016 · Medical devices · Medical devices · Type III
- Brilliance ICT Systems and Ingenuity CT System (2016-10-12)November 3, 2016 · Medical devices · Medical devices · Type III
- Brilliance 40/64 Slice CT System, Ingenuity CT System (2016-08-29)August 29, 2016 · Medical devices · Medical devices · Type II
- Brilliance and Ingenuity CT and ICT System (2016-04-21)May 17, 2016 · Medical devices · Medical devices · Type III
- Brilliance and Ingenuity CT and ICT System (2016-05-02)May 16, 2016 · Medical devices · Medical devices · Type III
- INGENUITY CT SYSTEM (2016-04-26)May 16, 2016 · Medical devices · Medical devices · Type III
- Philips Brilliance and Ingenuity Systems (2016-02-12)March 10, 2016 · Medical devices · Medical devices · Type III
- INGENUITY CT SYSTEM (2015-04-22)October 14, 2015 · Medical devices · Health products · Type II
- BRILLIANCE CT AND INGENUITY CT SYSTEM (2015-09-17)October 8, 2015 · Medical devices · Health products · Type II
- BRILLIANCE AND INGENUITY CT SYSTEMS (2015-07-30)August 18, 2015 · Medical devices · Health products · Type III
- Ingenuity CT System (2015-02-19)March 20, 2015 · Medical devices · Health products · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.