Data / Medical devices / Canada / ResolutionMD, Inc.
ResolutionMD, Inc.: FDA-registered device maker in CALGARY Alberta, Canada, 2 510(k) clearances
ResolutionMD, Inc. is registered with the FDA (registration 3006123366) in CALGARY Alberta, Canada. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated July 21, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006123366
- Address
- Suite 314, 1212 31 Avenue NE, CALGARY Alberta, Canada, T2E 7S8
- Owner or operator
- ResolutionMD, Inc. (9090399)
- Roles
- Manufacturer
- First device listed
- December 9, 2016
- Registered through
- 2026
- Brand names listed
- ResolutionMD, Synapse Mobility
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 |
|---|---|---|---|---|---|---|
| July 21, 2026 | K260500 | ResolutionMD | LLZ | Substantially Equivalent | ResolutionMD, Inc. | accessdata.fda.gov |
| August 24, 2016 | K161130 | ResolutionMD | LLZ | Substantially Equivalent | Calgary Scientific, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 21, 2026. 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.