FDA 510(k)

TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System

K-Number: K250913 · 2025-07-19

ApplicantJiangsu Tingsn Technology Co., Ltd.

Decision Date2025-07-19

Product CodeOBJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System is a medical device manufactured by Jiangsu Tingsn Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-19 under approval number K250913. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System?

TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2025-07-19. It is manufactured by Jiangsu Tingsn Technology Co., Ltd.. The 510(k) number is K250913.

When was TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System approved by the FDA?

TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System received FDA 510(k) clearance on 2025-07-19, under approval number K250913.

What company makes TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System?

TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System is manufactured by Jiangsu Tingsn Technology Co., Ltd..

What is the FDA product code for TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System?

The FDA product code for TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System is OBJ.

Related Clinical Trials

NCT07040696 Accuracy of Venous Excess Ultrasound Score at Hospital Admission to Predict Acute Kidney Injury COMPLETED NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07614100 Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves NOT_YET_RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT07613918 Brain Blood Flow and Cerebral Autoregulation Monitoring in Critically Ill Children NOT_YET_RECRUITING NCT05857852 Low-Intensity Focused Ultrasound for Cocaine Use Disorder COMPLETED

Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025) PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

Related Devices (Code: OBJ)

K160583REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short TipVolcano Corporation K160514OptiCross 18, 30 MHz Peripheral Imaging CatheterBoston Scientific Corporation K161125OptiCross X, 40 MHz Coronary Imaging CatheterBoston Scientific Corporation K153617OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)Boston Scientific Corporation K173618ACUSON AcuNav Volume Intracardiac Echocardiography CatheterSiemens Medical Solutions USA, Inc. K173284OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)Boston Scientific Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.