APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM— 510(k) K103645

Substantially Equivalent

Toshiba Medical Systems Corporation, Japan

FDA 510(k) clearance K103645 for APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, Substantially Equivalent on 2011-01-12. Applicant: Toshiba Medical Systems Corporation, Japan.

Clearance details

Applicant: Toshiba Medical Systems Corporation, Japan
Product code: Code ITX
Advisory panel: Radiology
Date received: 2010-12-13
Decision date: 2011-01-12
Decision: Substantially Equivalent
Clearance type: Special
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.