ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM— 510(k) K093713

Substantially Equivalent

Civco Medical Instruments

FDA 510(k) clearance K093713 for ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM, Substantially Equivalent on 2010-01-19. Applicant: Civco Medical Instruments.

Clearance details

Applicant: Civco Medical Instruments
Product code: Code ITX
Advisory panel: Radiology
Date received: 2009-12-01
Decision date: 2010-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Appollo Beach, FL, 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.