FDA 510(k) clearance · back to tracker

TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System

Jiangsu Tingsn Technology Co., Ltd. cleared K250913 on 2025-07-19, decision: substantially equivalent

K-number

K250913

Sponsor

Jiangsu Tingsn Technology Co., Ltd.

Device

TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-07-19

Product code

OBJ

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.1200

Official FDA record

Open K250913on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K250913 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.