Cleared Traditional

TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System

K250913 · Jiangsu Tingsn Technology Co., Ltd. · Cardiovascular

Jul 2025

Decision

114d

Days

Class 2

Risk

About This 510(k) Submission

K250913 is an FDA 510(k) clearance for the TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System, a Catheter, Ultrasound, Intravascular (Class II — Special Controls, product code OBJ), submitted by Jiangsu Tingsn Technology Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on July 19, 2025, 114 days after receiving the submission on March 27, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number	K250913 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 27, 2025
Decision Date	July 19, 2025
Days to Decision	114 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	OBJ — Catheter, Ultrasound, Intravascular
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1200
Definition	For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.