← Product Code [IYN](/productcode/IYN) · K261617

# Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic Ultrasound System (Resona I10);Diagnostic Ultrasound System (Resona I10S);Diagnostic Ultrasound System (Resona XI);Diagnostic Ultrasound System (Resona I10 CV);Diagnostic Ultrasound System (Nuewa I10W);Diagnostic Ultrasound System (Nuewa I10 Exp);Diagnostic Ultrasound System (Nuewa I10);Diagnostic Ultrasound System (Nuewa I10S);Diagnostic Ultrasound System (Nuewa XI);Diagnostic Ultrasoun (K261617)

_Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Oct 8, 2026 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K261617

## Device Facts

- **Applicant:** Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- **Product Code:** [IYN](/productcode/IYN.md)
- **Decision Date:** Oct 8, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1550
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

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**Source:** [https://fda.innolitics.com/device/K261617](https://fda.innolitics.com/device/K261617)

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