Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4— 510(k) K173090

Substantially Equivalent

Toshibamedical Systems Corporation

FDA 510(k) clearance K173090 for Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4, Substantially Equivalent on 2018-01-11. Applicant: Toshibamedical Systems Corporation.

Clearance details

Applicant: Toshibamedical Systems Corporation
Product code: Code IYN
Advisory panel: Radiology
Date received: 2017-09-29
Decision date: 2018-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Otawara-Shi, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

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.