APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM— 510(k) K121422

Substantially Equivalent

Toshiba Medical Systems Coporation, Japan

FDA 510(k) clearance K121422 for APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, Substantially Equivalent on 2012-08-16. Applicant: Toshiba Medical Systems Coporation, Japan.

Clearance details

Applicant: Toshiba Medical Systems Coporation, Japan
Product code: Code IYO
Advisory panel: Radiology
Date received: 2012-05-14
Decision date: 2012-08-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Tustin, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.