TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System— 510(k) K250913

Name: FDA 510(k) clearance K250913
Creator: U.S. Food and Drug Administration
Published: 2025-07-19

Substantially Equivalent

Jiangsu Tingsn Technology Co., Ltd.

FDA 510(k) clearance K250913 for TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System, Substantially Equivalent on 2025-07-19. Applicant: Jiangsu Tingsn Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Jiangsu Tingsn Technology Co., Ltd.
Product code: Code OBJ
Device class: Class 2
Regulation: 21 CFR 870.1200
Advisory panel: Cardiovascular
Date received: 2025-03-27
Decision date: 2025-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanjing, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OBJ

product code OBJ

Death: 38
Injury: 634
Malfunction: 3,453
Total: 4,125

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.