# K243298: Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Carbon (Shenzhen) Medical Device Co., Ltd.
- Decided: Apr 3, 2025 after 167 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 27 generations back to K935595 (1995). 239 ancestors in all.
No later device cites it as a predicate yet.
0 of 240 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202785: Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System, Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. (2021) Summary page 6.

## Indications for use
Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System is applicable for adults. It is intended for use in abdominal, superficial organs, trans-rectal, musculo-skeletal, peripheral vessel, urology exams. Modes of operation include: B, B+C, B+C+D(PW), B+M Mode, Image fusion, Needle Line. This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display of the human body and fluid, which is intended to be used in a hospital or medical clinic.

Source page: https://510kreport.com/device/K243298
Methodology: https://510kreport.com/methodology