# K240676: ULTIMUS Series Ultrasound Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: Vinno Technology (Suzhou) Co.,Ltd
- Decided: Dec 16, 2024 after 280 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: 23 generations back to K935595 (1995). 155 ancestors in all.
No later device cites it as a predicate yet.
0 of 156 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231966: Logiq E10, GE Medical Systems Ultrasound and Primary Care Diagnostics (2023) Summary page 6.

## Indications for use
The ULTIMUS Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospitals or clinics environment. The systems support the following clinical applications: This device is indicated for Abdominal; Fetal/Obstetrics; Gynecology; Transvaginal; Urology(including prostate); Transrectal; Cardiac(adult and child); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle, Musculo-skeletal Conventional and Superficial); Pediatrics(including neonatal cephalic); interventional(nerve block and vascular access); Adult Cephalic diagnostic Ultrasound applications. Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

Source page: https://510kreport.com/device/K240676
Methodology: https://510kreport.com/methodology