CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS— 510(k) K091804

Substantially Equivalent

Philips Ultrasound, Inc.

FDA 510(k) clearance K091804 for CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, Substantially Equivalent on 2009-07-17. Applicant: Philips Ultrasound, Inc..

Clearance details

Applicant: Philips Ultrasound, Inc.
Product code: Code ITX
Advisory panel: Radiology
Date received: 2009-06-18
Decision date: 2009-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

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.