Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6)
Shantou Institute of Ultrasonic Instruments Co., Ltd.The Readius series (L15, P8, V6, C6) are digital color Doppler ultrasound imaging systems designed for diagnostic use by qualified physicians. They support various scanning modes to image abdominal areas, small organs like the thyroid and breast, and peripheral vascular structures. The systems enable B-mode, M-mode and advanced Doppler flow imaging to assist clinicians in evaluating blood flow and tissue characteristics in real time.
Intended Use
The Readius L15/P8/V6/C6 Digital Color Doppler Ultrasound Imaging System is a general purpose diagnostic ultrasound system intended for use by trained physicians in hospitals or clinics to evaluate abdominal, small organs (thyroid, testes, breast), and peripheral vascular applications with multiple imaging modes including B-Mode, M-mode, Color Flow Map, and Doppler.
Technology
The system uses multi-mode ultrasound scanning techniques including linear, convex, and phased array with color Doppler capabilities, transmitting image data via WiFi to handheld devices for display. It supports advanced Doppler imaging modes and has similar technical and safety features as its predicate device (Apogee 2300).
Performance
The device underwent non-clinical testing compliant with multiple international and FDA standards for safety, electromagnetic compatibility, software life cycle, usability, and biocompatibility. Clinical testing was deemed unnecessary based on equivalence to predicate device. Testing demonstrated the device is as safe and effective as its legally marketed predicate.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/30/2024
2 months - 2
FDA Approval
12/10/2024
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