Data / Medical devices / Canada / Imeka Solutions Inc.
Imeka Solutions Inc.: FDA-registered device maker in Sherbrooke Quebec, Canada, 2 510(k) clearances
Imeka Solutions Inc. is registered with the FDA (registration 3027977501) in Sherbrooke Quebec, Canada. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 22, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027977501
- Address
- 195 rue Belvedere Nord Office 201, Sherbrooke Quebec, Canada, J1H 4A7
- Owner or operator
- Imeka Solutions Inc. (10088605)
- Roles
- Manufacturer
- First device listed
- August 28, 2023
- Registered through
- 2026
- Brand names listed
- ANDI
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| October 22, 2025 | K252298 | ANDI 2.0 | QIH | Substantially Equivalent | Imeka Solutions, Inc. | accessdata.fda.gov |
| July 25, 2023 | K230913 | ANDI | QIH | Substantially Equivalent | Imeka Solutions, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of System, Image Processing, Radiological
Updated October 22, 2025. 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.