Data / Medical devices / Canada / Voronoi Health Analytics Inc
Voronoi Health Analytics Inc: FDA-registered device maker in Vancouver British Columbia, Canada, 1 510(k) clearance
Voronoi Health Analytics Inc is registered with the FDA (registration 3045078825) in Vancouver British Columbia, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 16, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3045078825
- Address
- 997 Seymour St #250, Vancouver British Columbia, Canada, V6B 3M1
- Owner or operator
- Voronoi Health Analytics Incorporated (10095478)
- Roles
- Manufacturer
- First device listed
- March 17, 2026
- Registered through
- 2026
- Brand names listed
- DAFS, Data Analysis Facilitation Suite, Data Analysis Facilitation Suite (DAFS)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 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 |
|---|---|---|---|---|---|---|
| March 16, 2026 | K253944 | Data Analysis Facilitation Suite (DAFS) | QIH | Substantially Equivalent | Voronoi Health Analytics Incorporated | accessdata.fda.gov |
Compare with other makers
Updated March 16, 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.