← Product Code [IYN](/productcode/IYN) · K261585

# Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound System (Nuewa A20 Exp); Diagnostic Ultrasound System (Nuewa A20 Elite); Diagnostic Ultrasound System (Nuewa A20Q); Diagnostic Ultrasound System (Nuewa A MV); Diagnostic Ultrasound System (Nuewa A Elite); Diagnostic Ultrasound System (Nuewa A MS); Diagnostic Ultrasound System (Nuewa A20 Premium); Diagnostic Ultrasound System (Nuewa A20 Plus); Diagnostic Ultrasound System (Nuewa A18 (K261585)

_Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Oct 16, 2026 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K261585

## Device Facts

- **Applicant:** Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- **Product Code:** [IYN](/productcode/IYN.md)
- **Decision Date:** Oct 16, 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/K261585](https://fda.innolitics.com/device/K261585)

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