Velacur One (LI-1100)— 510(k) K251728

Substantially Equivalent

Sonic Incytes Medical Corp

FDA 510(k) clearance K251728 for Velacur One (LI-1100), Substantially Equivalent on 2025-06-26. Applicant: Sonic Incytes Medical Corp.

Clearance details

Applicant: Sonic Incytes Medical Corp
Product code: Code IYO
Advisory panel: Radiology
Date received: 2025-06-05
Decision date: 2025-06-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Vancouver, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.