Ultrasound System 2300
BK Medical ApsUltrasound System 2300 is a mobile, software-controlled diagnostic ultrasound system designed for a wide range of clinical applications including fetal, abdominal, pediatric, neuro, cardiac, and musculoskeletal imaging among others. It supports multiple ultrasound modes such as B-Mode, Doppler, Elastography, and Contrast Imaging to assist qualified healthcare professionals in imaging and guiding puncture and biopsy procedures, thereby improving diagnostic confidence and procedural accuracy.
Intended Use
The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance.
Technology
The system is a mobile, software-controlled ultrasound device with multiple configurations aimed at different clinical applications. It consists of a scan engine with digital acquisition and processing, a 19-inch clinical display, keyboard or touch interface, and supports a wide variety of transducers (linear, curved, phased arrays, endocavity). It operates in multiple imaging modes such as B-Mode, M-Mode, Doppler, Elastography, and Contrast Imaging to generate diagnostic quality images. It runs Windows 10 and interfaces with needle tracking accessories.
Performance
The device underwent bench testing for electrical safety, electromagnetic compatibility, ultrasonic performance, and software life-cycle processes per international standards. The AI feature Prostate Volume Assist was validated with clinical datasets demonstrating volume measurement accuracy within accepted deviation limits, verified by clinical experts. No animal or clinical studies were required for this 510(k).
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/21/2022
3 months - 2
FDA Approval
4/11/2023
Other devices from BK Medical Aps
- Ultrasound System 13002023 • 510K
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