# K221911: Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXP

- Pathway: 510(k) (Special)
- Applicant: Vinno Technology (Suzhou) Co.,Ltd
- Decided: Dec 21, 2022 after 174 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: 20 generations back to K935595 (1995). 224 ancestors in all.
No later device cites it as a predicate yet.
6 of 225 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190120: Vinno 8, Vinno 6, Vinno 5, Vinno Technology (Suzhou) Co.,Ltd (2020) Summary page 4.

## Indications for use
The device is general purpose diagnostic ultrasound system for use by qualified healthcare professionals. It is applicable for adults, pregnant women, pediatric patients and neonates. The device is intended for ultrasound imaging, measurement and analysis of human body and fluid for multiple clinical applications including: abdominal (GYN and Urology), Thoracic/Pleural, Fetal/Ob, small organ (including breast, thyroid, testes), peripheral vessel, neonatal cephalic, adult cephalic, pediatric, musculo-skeletal (conventional, superficial), trans-rectal, trans-vaginal, cardiac adult, cardiac pediatric, magnetic Needle guidance and imaging guidance of interventional procedures (e.g. biopsy). This device is intended to use by, or by the order of, and under the supervision of a licensed physician qualified to direct the use of the device. The device is used in hospital, clinics and clinical point-of-care for diagnosis of patients. 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, CBI, EI, Combine modes.

Source page: https://510kreport.com/device/K221911
Methodology: https://510kreport.com/methodology