Data / Medical devices / Canada / Realize Medical Inc.
Realize Medical Inc.: FDA-registered device maker in Ottawa Ontario, Canada, 1 510(k) clearance
Realize Medical Inc. is registered with the FDA (registration 3021163566) in Ottawa Ontario, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 17, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021163566
- Address
- 7 Bayview Station Road, Ottawa Ontario, Canada, K1Y 2C5
- Owner or operator
- Realize Medical Inc. (10087244)
- Roles
- Manufacturer
- First device listed
- October 26, 2023
- Registered through
- 2026
- Brand names listed
- Elucis
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 17, 2023 | K220649 | Elucis | LLZ | Substantially Equivalent | Realize Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 17, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.