# K223917: Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno X2E,Vinno X2P

- 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: 23 generations back to K935595 (1995). 189 ancestors in all.
No later device cites it as a predicate yet.
0 of 190 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173369: DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. (2017) Summary page 5.

## Indications for use
The device is intended for ultrasound imaging, measurement, display and analysis of the human body and fluid. The operating modes supported by the device are B, M,PWD CWD, Tissue Doppler, Color Doppler, Color M Doppler, Power Doppler, Tissue Velocity Imaging, Harmonic Imaging, 3D/4D, Combine modes. This device is indicated for Abdominal; Fetal; Obstetrics; gynecology;Trans-vaginal; Urology(including prostate); Trans-rectal; 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. This device is intended to use by, or by the order of, and under the supervision of an appropriately-trained healthcare professional qualified to direct the use of the device in hospitals or clinics.

Source page: https://510kreport.com/device/K223917
Methodology: https://510kreport.com/methodology