MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00— 510(k) K072918

Substantially Equivalent

Toshibamedical Systems Corporation

FDA 510(k) clearance K072918 for MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00, Substantially Equivalent on 2007-10-29. Applicant: Toshibamedical Systems Corporation.

Clearance details

Applicant: Toshibamedical Systems Corporation
Product code: Code ITX
Advisory panel: Radiology
Date received: 2007-10-15
Decision date: 2007-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

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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.