SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)— 510(k) K080555

Substantially Equivalent

Ivu Imaging Corporation

FDA 510(k) clearance K080555 for SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS), Substantially Equivalent on 2008-06-03. Applicant: Ivu Imaging Corporation.

Clearance details

Applicant: Ivu Imaging Corporation
Product code: Code ITX
Advisory panel: Radiology
Date received: 2008-02-28
Decision date: 2008-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grapevine, TX, 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.