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Sonic Incytes Medical Corp

Canada(FDA 510(k) applicant) Last updated 25 Oct 2026

Devices
3
Registries
GUDIDFDA 510(k)FDA
FDA recalls
0

Catalogue3

What Sonic Incytes Medical Corp makes

Sonic Incytes Medical Corp manufactures hepatic ultrasound elastography systems designed to assess liver stiffness and fibrosis. These devices include the Velacur ONE, Velacur, and Velacur One (LI-1100), which use elastography technology to provide quantitative measurements for diagnostic evaluation of liver conditions.

The company’s portfolio is regulated under Class II medical devices in the US, with products listed under FDA 510(k) and FDA UDI registries. The manufacturer operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Sonic Incytes Medical Corp manufacture?

Sonic Incytes Medical Corp specializes in hepatic ultrasound elastography systems. These devices, such as the Velacur ONE, Velacur, and Velacur One (LI-1100), are designed to measure liver stiffness and assess fibrosis using elastography technology. The focus is on diagnostic tools for evaluating liver conditions.

Where is Sonic Incytes Medical Corp based?

Sonic Incytes Medical Corp is headquartered in the United States. The company’s location influences its regulatory compliance, particularly under US standards like FDA requirements.

Which regulatory registries list Sonic Incytes Medical Corp’s devices?

Sonic Incytes Medical Corp’s devices are listed under the FDA 510(k) premarket notification process and the FDA Unique Device Identifier (UDI) system. These registries ensure traceability and compliance for Class II devices in the US market.

How are Sonic Incytes Medical Corp’s devices classified under US regulations?

Sonic Incytes Medical Corp’s devices fall under Class II classification in the US. This classification applies to moderate-risk medical devices that require special controls to ensure safety and effectiveness, such as pre-market notifications (510(k)) before commercial distribution.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Canada(Country (from FDA 510(k) applicant address))
Address
936 8th Ave W, Vancouver British Columbia
FDA FEI number
3016253057
DUNS number
203863610