Ultimax-i, DREX-UI80 V1.60— 510(k) K170832

Substantially Equivalent

Toshibamedical Systems Corporation

FDA 510(k) clearance K170832 for Ultimax-i, DREX-UI80 V1.60, Substantially Equivalent on 2017-07-21. Applicant: Toshibamedical Systems Corporation.

Clearance details

Applicant: Toshibamedical Systems Corporation
Product code: Code OWB
Advisory panel: Radiology
Date received: 2017-03-20
Decision date: 2017-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Otawara-Shi, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

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.