# K243132: Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6)

- Pathway: 510(k) (Traditional)
- Applicant: Shantou Institute of Ultrasonic Instruments Co., Ltd.
- Decided: Dec 10, 2024 after 71 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: 21 generations back to K935595 (1995). 181 ancestors in all.
No later device cites it as a predicate yet.
0 of 182 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173000: Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System, Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) (2017) Summary page 6.

## Indications for use
Readius L15/ Readius P8/ Readius V6/ Readius C6 Digital Color Doppler Ultrasound Imaging System is a general purpose diagnostic ultrasound system intended to be used by a trained/qualified physician in a hospital or clinical setting for ultrasound evaluation of abdominal, small organ (thyroid, testes, breast), and peripheral vascular applications in B-Mode, M-mode, Color Flow Map (CFM), Vector Space Flow (VS Flow), Color Power Angio (CPA), Pulsed Wave (PW) and Panoscope.

Source page: https://510kreport.com/device/K243132
Methodology: https://510kreport.com/methodology