TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System
FDA 510(k) K250913 · Jiangsu Tingsn Technology Co., Ltd.
510(k) numberK250913
Submission
- Device name
- TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System
- Applicant
- Jiangsu Tingsn Technology Co., Ltd.
Nanjing, CN - Received
- March 27, 2025
- Decision date
- July 19, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBJ – Catheter, Ultrasound, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
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| K251231 | ViewFlex X ICE Catheter, Sensor EnabledOBJ · Special | Abbott Medical | 05/20/2025SE |
| K251103 | VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac…OBJ · Special | Philips Image Guided Therapy Corporation | 05/09/2025SE |
| K242893 | VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemOBJ · Traditional | Luma Vision Limited | 03/24/2025SE |
Questions and answers
When was TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System cleared by the FDA?
TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System (K250913) received a 510(k) decision of Substantially Equivalent on July 19, 2025, 114 days after the submission was received.
What is the product code of K250913?
The FDA product code is OBJ – Catheter, Ultrasound, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 870.1200.