Envision ultrasound pad and cover— 510(k) K190802

Substantially Equivalent

Civco Medical Solutions

FDA 510(k) clearance K190802 for Envision ultrasound pad and cover, Substantially Equivalent on 2019-05-24. Applicant: Civco Medical Solutions.

Clearance details

Applicant: Civco Medical Solutions
Product code: Code ITX
Advisory panel: Radiology
Date received: 2019-03-29
Decision date: 2019-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalona, IA, 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.