← Product Code [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN) · K253716

# uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super (K253716)

_Wuhan United Imaging Healthcare Co.,Ltd · IYN · May 15, 2026 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K253716

## Device Facts

- **Applicant:** Wuhan United Imaging Healthcare Co.,Ltd
- **Product Code:** [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN.md)
- **Decision Date:** May 15, 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.

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K253716](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K253716)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com