Velacur— 510(k) K232459

Substantially Equivalent

Sonic Incytes

FDA 510(k) clearance K232459 for Velacur, Substantially Equivalent on 2023-09-12. Applicant: Sonic Incytes.

Clearance details

Applicant: Sonic Incytes
Product code: Code IYO
Advisory panel: Radiology
Date received: 2023-08-15
Decision date: 2023-09-12
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.