DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM— 510(k) K113632

Substantially Equivalent

Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.

FDA 510(k) clearance K113632 for DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, Substantially Equivalent on 2012-01-25. Applicant: Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd..

Clearance details

Applicant: Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2011-12-05
Decision date: 2012-01-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.