# K221568: KOLO Evolution XHD Series Ultrasound Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: Kolo Medical (Suzhou) Co., Ltd.
- Decided: Sep 12, 2022 after 104 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: 3 generations back to K062571 (2006). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190476: FUJIFILM Sonosite Vevo MD Imaging System, FUJIFILM Sonosite, Inc. (2019) Summary page 4.

## Indications for use
The Evolution XHD Series Ultrasound Diagnostic System is a high frequency 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 hospital environment. The systems support the following clinical applications: The Evolution XHD Series Diagnostic Ultrasound System is applicable for adult and pediatric. It is intended for use in Pediatric, Small parts (breast, thyroid, testicles, prostate), Peripheral vessel, Dermatological, Musculoskeletal (conventional), Musculoskeletal (superficial). Modes of operation include: B Mode, Color Doppler, Power Doppler, PW Doppler, Combined modes: B+Color Doppler, B+Power Doppler, B+PW Doppler.

Source page: https://510kreport.com/device/K221568
Methodology: https://510kreport.com/methodology