Data / Medical devices / System, Imaging, Pulsed Echo, Ultrasonic / Canada
FDA-registered makers of System, Imaging, Pulsed Echo, Ultrasonic in Canada: 7 establishments
7 establishments in Canada are registered with the FDA to make System, Imaging, Pulsed Echo, Ultrasonic (product code IYO). 2 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- System, Imaging, Pulsed Echo, Ultrasonic
- Product code
- IYO
- Country
- Canada
Makers of System, Imaging, Pulsed Echo, Ultrasonic in Canada
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Exact Imaging, Inc. | Markham Ontario, Canada | Manufacturer, Specification developer | 2 | April 30, 2018 | 0 | 0 | 0 | api.fda.gov |
| Sonic Incytes Medical Corp | Vancouver British Columbia, Canada | Complaint file establishment, Manufacturer | 2 | June 26, 2025 | 0 | 0 | 0 | api.fda.gov |
| Clarius Mobile Health Corp. | Vancouver British Columbia, Canada | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Conavi Medical Inc | Toronto Ontario, Canada | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fujifilm Visualsonics, Inc. | TORONTO Ontario, Canada | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sonele Inc. | Markham Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ventripoint Diagnostics Ltd. | Toronto Ontario, Canada | Complaint file establishment, Manufacturer | 0 | 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.