# K223920: Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55, Vinno E35, Vinno X65, Vinno X55, Vinno X35, Vinno G55E, Vinno G55P, Vinno M55E, Vinno M55P, Vinno E35E, Vinno E35P

- Pathway: 510(k) (Traditional)
- Applicant: Vinno Technology (Suzhou) Co.,Ltd
- Decided: Jun 17, 2023 after 170 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: 29 generations back to K924432 (1993). 279 ancestors in all.
No later device cites it as a predicate yet.
0 of 280 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180409: HS40 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2018) Summary page 4.

## Indications for use
The device is a general purpose diagnostic ultrasound system intended for use by appropriately trained healthcare professionals in a hospital setting. The device is intended for ultrasound imaging, measurement, display and analysis of the human body and fluid. This device is indicated for Abdominal; Fetal/Obstetrics; Gynecology;Transvaginal; Urology(including prostate); Transrectal; Cardiac(adult and pediatric); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle, Musculo-skeletal Conventional and Superficial); Pediatrics(including neonatal cephalic); and Adult Cephalic diagnostic Ultrasound applications. The operating modes supported by the device are B mode, Harmonic mode, M mode, Color Flow mode, Power-Doppler mode, Pulsed Wave Doppler mode, Continuous Wave Doppler, 3D mode, 4D mode, Spatio Temporal Image Correlation mode, Tissue Doppler mode, Tissue Velocity Imaging mode, Elastography mode and Contrast Agent Imaging mode.

Source page: https://510kreport.com/device/K223920
Methodology: https://510kreport.com/methodology