# K190476: FUJIFILM Sonosite Vevo MD Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: FUJIFILM Sonosite, Inc.
- Decided: Mar 15, 2019 after 16 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: 2 generations back to K062571 (2006). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160674: Fujifilm Sonosite Vevo MD Imaging System, FUJIFILM Sonosite, Inc. (2016) Summary page 8.

## Most influential descendants
- K233112: HM70 EVO Diagnostic Ultrasound System (2023), 2 descendants of its own
- K254099: EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System (2026), 1 descendant of its own
- K263182: EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound System (2026), 0 descendants of its own
- K221568: KOLO Evolution XHD Series Ultrasound Diagnostic System (2022), 0 descendants of its own

## Indications for use
The Vevo MD Imaging System is a general purpose imaging system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Abdominal Dermatological Musculoskeletal (conventional) Musculoskeletal (superficial) Neonatal Cephalic Ophthalmic Pediatric Peripheral vessel Small Organ (breast, thyroid, testicles, prostate)

Source page: https://510kreport.com/device/K190476
Methodology: https://510kreport.com/methodology