UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM— 510(k) K081919

Substantially Equivalent

Fukuda Denshi Co., Ltd.

FDA 510(k) clearance K081919 for UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM, Substantially Equivalent on 2008-09-09. Applicant: Fukuda Denshi Co., Ltd..

Clearance details

Applicant: Fukuda Denshi Co., Ltd.
Product code: Code ITX
Advisory panel: Radiology
Date received: 2008-07-07
Decision date: 2008-09-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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.