Medical device licence · 105950 · Class 3
LUMINOS LOTUS MAX
Yes: licensed in Canada
Licence status Issued (active); first licensed March 17, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 105950
- Licence holder
- Siemens Healthcare GmbhErlangen, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 17, 2021
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- LUMINOS LOTUS MAX
- LUMINOS LOTUS 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
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.