FDA 510(k) ClearanceIYN
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
FDA 510(k) K253716 · Wuhan United Imaging Healthcare Co.,Ltd
- 510(k) number
- K253716
- Device name
- 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
- Applicant
- Wuhan United Imaging Healthcare Co.,Ltd
- Product code
- IYN
- Decision
- Substantially Equivalent
- Decision date
- Device class
- Class 2
- Regulation number
- 892.1550
- Advisory committee
- RA
- Medical specialty
- Radiology
Candidate predicate devices
Other devices cleared under product code IYN form a screening cohort, not a predicate determination. Compare intended use, technological characteristics, performance evidence, labeling, and current legal-marketing status before selecting a predicate.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261668 | Venue Go | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | |
| K262311 | Alturion Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | |
| K261288 | Handheld Ultrasound Scanner | IMGFAX CO., LTD. | |
| K261835 | LOGIQ Focus | GE Medical Systems Ultrasound and Primary Care Diagnostics | |
| K261412 | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System; | Samsung Medison Co., Ltd. | |
| K261211 | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | |
| K261081 | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) | Beijing Konted Medical Technology Co.,Ltd | |
| K261272 | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system | Esonic Technology (Wuhan) Co., Ltd. | |
| K260667 | Alturion Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | |
| K260844 | ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | |
| K260748 | ES-Series | E-Scopics | |
| K260123 | EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound, LLC |
Building a 510(k) around this device type?
Assyro turns predicate research into a substantial-equivalence comparison and an eSTAR-ready 510(k) workflow — so predicate strategy, testing evidence, and labeling stay aligned before FDA review.