510(k) K251250— ViewMate Multi Ultrasound System (VMM-ICE-01); ViewMate Multi Ultrasound System (VMM-ICE-02)

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: 2025-04-23
Decision date: 2025-09-05
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.