K190206

Substantially Equivalent

DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System

Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Product code: IYN
Advisory panel: Radiology
Date received: 2019-02-04
Decision date: 2019-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

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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.