# K250913: TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Tingsn Technology Co., Ltd.
- Decided: Jul 19, 2025 after 114 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 27 generations back to K935595 (1995). 280 ancestors in all.
No later device cites it as a predicate yet.
0 of 281 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221148: Vivid iq, GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (2022) Summary page 5.
- K092064: Soundstar 3D Ultrasound Catheter, Model M-5723-12, Biosense Webster, Inc. (2009) Summary page 6.

## Indications for use
TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. Modes of operation include: B,M, Color Doppler,PW Doppler, CW Doppler,Power Doppler; Combined modes: B/M,B/Color,B/M/Color, B/PWD, B/CWD, B/Color/PWD, B/Color/CWD, B/Power. The device is intended for use in Professional healthcare facility environment including echo lab, other hospital settings, operating room, Cath lab and EP lab. The intended users of the Device is to be used exclusively by physicians who are appropriately trained personnel in a fully equipped electrophysiology or catheterization room or under their direct supervision.

Source page: https://510kreport.com/device/K250913
Methodology: https://510kreport.com/methodology