510(k) K241432— MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System

Substantially Equivalent

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Clearance details

Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Product code: Code IYN
Advisory panel: Radiology
Date received: 2024-05-21
Decision date: 2024-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

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.