FDA.reportPublic FDA data

Color Doppler Diagnostic Ultrasound System

Primary DI
06975345060108
Brand
Color Doppler Diagnostic Ultrasound System
Company
Jiangsu Tingsn Technology Co., Ltd.
Model
TINGSN FINDERS 2
Published
2026-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250913000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250913000TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.2025-07-19OBJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975345060108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975345060108069753450601086975345060108

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular ultrasound imaging systemAn assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) imaging procedures involving the heart and blood vessels. Included are software packages that support a variety of static or real-time cardiac specific imaging applications used to diagnose anatomical defects of the heart, determine blood flow characteristics and functional/anatomical problems associated with myocardial infarction. It is used to generate ultrasound pulses, direct them to a target area, detect the echoes, and process the resulting information to produce and display static or dynamic two or three-dimensional (3-D) images.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
603360725
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16975345061102Disposable Intracardiac Echocardiography CatheterTINGSN Sonic Eyes 10 Eco2026-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953121382VolusonGE Ultrasound Korea Ltd.IYN2026-05-28
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
08056304455826MyLabC25ESAOTE SPAIYO2025-12-10
08056304455833MyLabC30ESAOTE SPAIYO2025-12-10
08056304455017MyLabA50ESAOTE SPAIYO2025-07-07
08056304455215MyLabE85ESAOTE SPAIYO2025-07-07
08056304455307MyLabA70ESAOTE SPAIYO2025-07-07
08056304455437MyLabA50ESAOTE SPAIYO2025-07-07
08056304455451MyLabA70ESAOTE SPAIYO2025-07-07
08056304455635MyLabE80ESAOTE SPAIYO2025-07-07
08056304455642MyLabE85ESAOTE SPAIYO2025-07-07
08056304455628MyLabE80ESAOTE SPAIYO2024-03-29
08056304454980MyLabX90ESAOTE SPAIYO2023-12-14
08056304455031MyLabOmega eXPESAOTE SPAIYO2023-12-14
08056304455031MyLabOmega eXPESAOTE SPAIYN2023-12-14
08056304454676MyLabX9ESAOTE SPAIYN2023-06-13
G055ABMVIVM031VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM041VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM071VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM081VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM111VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM121VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVU010VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM010VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM020VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM050VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM060VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM090VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVM100VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30
G055ABMVIVR010VIVACE ULTRAAesthetics Biomedical, Inc.IYO2022-12-30