Medical device licence · 98448 · Class 3
LUMINOS AGILE MAX
Yes: licensed in Canada
Licence status Issued (active); first licensed January 24, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 98448
- Licence holder
- Siemens Healthcare GmbhErlangen, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 24, 2017
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- LUMINOS AGILE MAX
- LUMINOS AGILE MAX - SYSTEM 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 “luminos”. A notice may cover another product or only some lots: read it to see what it covers.
- Luminos Lotus Max, dRF Max, and Agile MaxAugust 19, 2024 · Radiology · Device compatibility · Type II
- Luminos dRF Max, MOBILETT Elara Max, YSIO Max and YSIO X.PreeJuly 5, 2024 · Radiology · Device compatibility · Type II
- Luminos, Uroskop and Axiom SystemsFebruary 24, 2023 · Radiology · Performance · Type II
- Luminos Agile MaxDecember 30, 2022 · Radiology · Performance · Type II
- Luminos And Axiom FootrestsDecember 23, 2022 · Radiology · Performance · Type II
- LUMINOS DRF MAX, UROSKOP OMNIA MAX, MULTITOM RAXApril 11, 2022 · Radiology · Software defect · Type II
- "Ysio Max, Luminos DRF Max, Uroskop Omnia Max & Multitom Rax (2020-04-28) "June 5, 2020 · Medical devices · Medical devices · Type III
- Ysio Max, Luminos DRF Max & Uroskop Omnia Max (2020-04-27)May 8, 2020 · Medical devices · Medical devices · Type III
- YSIO Max, Luminos DRF, Uroskop Omni Max, Luminos Agile Max (2020-01-17)January 31, 2020 · Medical devices · Medical devices · Type II
- Ysio Max, Luminos dRF Max, Uroskop Omnia Max (2019-05-08)May 31, 2019 · Medical devices · Medical devices · Type III
- Ysio Max, Luminos dRF Max, and Uroskop Omnia Max (2018-12-11)January 9, 2019 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.