Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)
Telefield Medical Imaging (Shenzhen) LimitedThe Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) by Telefield Medical Imaging is a portable, software-controlled ultrasound system designed for real-time visualization of anatomical structures and blood flow using B-mode, color Doppler, and pulsed wave imaging. It aids healthcare professionals by providing detailed imaging and fluid flow analysis across multiple body regions such as abdominal, musculoskeletal, and vascular areas, facilitating diagnosis at the point of care.
Intended Use
The Portable Digital Color Doppler Ultrasound System is intended for ultrasound imaging in B (2D), Color Doppler and Pulsed Wave imaging modes. It is indicated for ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Small Organ, Musculoskeletal, Peripheral Vessel, Urology, and Carotid. It is intended for use by qualified healthcare professionals.
Technology
The system is a portable, general-purpose, software-controlled ultrasound system consisting of a handheld main unit and software. It produces real-time ultrasound images emphasizing anatomic structure detail and blood flow evaluation using color Doppler technology. Features include measurements, image storage, review, printing, and recording capabilities.
Performance
The device has passed several non-clinical performance tests including electrical safety, electromagnetic compatibility, usability, ultrasonic safety, and software lifecycle processes, demonstrating comparable safety and effectiveness to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/31/2024
4 months - 2
FDA Approval
10/24/2024
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