Data / Medical devices / Automated Radiological Image Processing Software / Canada
FDA-registered makers of Automated Radiological Image Processing Software in Canada: 7 establishments
7 establishments in Canada are registered with the FDA to make Automated Radiological Image Processing Software (product code QIH). 7 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Automated Radiological Image Processing Software
- Product code
- QIH
- Country
- Canada
Makers of Automated Radiological Image Processing Software in Canada
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Clarius Mobile Health Corp. | Vancouver British Columbia, Canada | Complaint file establishment, Manufacturer | 5 | March 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Circle Cardiovascular Imaging Inc | Calgary Alberta, Canada | Manufacturer | 4 | October 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| Change Healthcare Canada Company | RICHMOND British Columbia, Canada | Exporter to the US, Manufacturer | 2 | January 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Imeka Solutions Inc. | Sherbrooke Quebec, Canada | Manufacturer | 2 | October 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Vitaa Medical Solutions Inc | Montreal Quebec, Canada | Complaint file establishment, Manufacturer | 2 | March 30, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ventripoint Diagnostics Ltd. | Toronto Ontario, Canada | Complaint file establishment, Manufacturer | 1 | February 26, 2025 | 0 | 0 | 0 | api.fda.gov |
| Voronoi Health Analytics Inc | Vancouver British Columbia, Canada | Manufacturer | 1 | March 16, 2026 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.