SONIXGPS NEEDLE SENSOR— 510(k) K111818

Substantially Equivalent

Ultrasonix Medical Corporation

FDA 510(k) clearance K111818 for SONIXGPS NEEDLE SENSOR, Substantially Equivalent on 2012-06-13. Applicant: Ultrasonix Medical Corporation.

Clearance details

Applicant: Ultrasonix Medical Corporation
Product code: Code IYO
Advisory panel: Radiology
Date received: 2011-06-28
Decision date: 2012-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, 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.