Data / Medical devices / Canada / Sonic Incytes Medical Corp
Sonic Incytes Medical Corp: FDA-registered device maker in Vancouver British Columbia, Canada, 2 510(k) clearances
Sonic Incytes Medical Corp is registered with the FDA (registration 3016253057) in Vancouver British Columbia, Canada. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 26, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016253057
- Address
- 936 8th Ave W, Vancouver British Columbia, Canada, V5Z 1E5
- Owner or operator
- Sonic Incytes (10077443)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- August 27, 2020
- Registered through
- 2026
- Brand names listed
- Velacur, Velacur ONE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| June 26, 2025 | K251728 | Velacur One (LI-1100) | IYO | Substantially Equivalent | Sonic Incytes Medical Corp | accessdata.fda.gov |
| July 31, 2020 | K201597 | Liver Incytes, Model 1005 | IYO | Substantially Equivalent | Sonic Incytes | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
Updated June 26, 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.