MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900— 510(k) K053346

Substantially Equivalent

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

FDA 510(k) clearance K053346 for MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900, Substantially Equivalent on 2005-12-09. Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd..

Clearance details

Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2005-12-02
Decision date: 2005-12-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Great Neck, NY, US

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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.