Radiology · 510(k) · 2026
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
Wuhan United Imaging Healthcare Co.,Ltd. Cleared by FDA on 15 May 2026 under submission K253716, product code IYN (system, imaging, pulsed doppler, ultrasonic). What FDA's record says, in FDA's words.
Device record · K253716
- Device. 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 SuperDEVICE
- Company. Wuhan United Imaging Healthcare Co.,Ltd (CN)COMPANY
- Decision. 15 May 2026, 510(k), substantially equivalent (traditional review); received 24 November 2025DECISION
- Panel. RadiologyPANEL
- Product code. IYN, System, Imaging, Pulsed Doppler, UltrasonicCODE
- Regulation. 21 CFR 892.1550, Class IIREG
- Source. FDA database entry · decision document (27 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
if it is known. This K253716Please type in the marketing application/submission number, textbox will be left blank for original applications/submissions. Please provide the device trade name(s). 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 Please provide your Indications Ifor Use below. The Ultrasonic Pulsed Doppler Imaging System is used for ultrasound scanning of the whole body. It is intended for use by qualified and trained healthcare professionals in a hospital or medical clinic to perform ultrasound diagnostic examinations, supporting the following clinical applications: Abdominal (including Renal, Gynecological, and Obstetric), Pediatric, Small Parts, Cranial(Neonatal Cephalic, Adult Cephalic), Cardiac, Peripheral Vascular, Musculoskeletal, Urological. Modes of operation include: B Mode, M Mode, Color Mode, PW Mode, CW Mode, 3D/4D Mode, Strain Elastography Imaging, Shear Wave Elastography Imaging. Combined modes: B/M, B/Color, B/PW, B/Color/ PW. I C) Please select the types of uses (select one or both, as Z Prescription Use (21 CFR 801 Subpart D) [ Over-The-Counter Use (21 CFR 801 Subpartapplicable). Wuhan United Imaging Healthcare Co., Ltd. Te l: +86 (21) 67076888 Fax：+86 (21) 67076889 www.united-imaging.com 1 of 23 510 (k) SUMMARY K253716
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedultrasound
- Mentionsa diagnostic claim
- Mentionsprescription use
- Mentionsadult patients
- Mentionspediatric patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 2,748 reports filed against devices carrying product code IYN. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · ACUSON Origin Ultrasound System · Siemens Medical Solutions USA, Inc. · report 3023245-2026-00096
30 September 2026 · Malfunction · ACUSON Sequoia Ultrasound System · Siemens Medical Solutions USA, Inc. · report 3023245-2026-00097
30 September 2026 · Malfunction · AFFINITI 30 · Philips Ultrasound, Inc · report 3019216-2026-100325
30 September 2026 · Injury · EPIQ 5G · Philips Ultrasound, Inc · report 3019216-2026-100326
29 September 2026 · Malfunction · ACUSON Juniper · Siemens Medical Solutions USA, Inc. · report 3023245-2026-00091
One of the patient exams performed on the Juniper system displays an "Unarchived" error message and they are unable to send this study to PACS. All other exams performed before are after this one are transferring over to the PACS as expected without any errors. The problem occurred after a Breast study was completed and the user tried to send it over to the network PACS. TSE worked with the customer and she confirmed that the problem cannot be reproduced, as it only is affecting this one exam. […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code IYN, in Radiology, from Wuhan United Imaging Healthcare Co.,Ltd, or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.