SONIX ULTRASOUND SCANNER— 510(k) K093462

Substantially Equivalent

Ultrasonix Medical Corporation

FDA 510(k) clearance K093462 for SONIX ULTRASOUND SCANNER, Substantially Equivalent on 2009-11-20. Applicant: Ultrasonix Medical Corporation.

Clearance details

Applicant: Ultrasonix Medical Corporation
Product code: Code ITX
Advisory panel: Radiology
Date received: 2009-11-06
Decision date: 2009-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.