Elucis is FDA 510(k) cleared (K220649) for clinical use in the United States. It is not licensed by Health Canada or CE marked. Outside the US, Elucis Next is available for research use only.
Realize Medical medical device software may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. In countries where no regulatory registration is obtained of Elucis, a non-clinical version, Elucis Next, is available. Please contact us if you have questions about the availability of Realize Medical medical device software in your area.
Compliance — Elucis is a Class II FDA 510(k) Cleared device — K220649
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