Ultrasound System 1300
BK Medical ApsThe Ultrasound System 1300 by BK Medical ApS is a mobile ultrasound system designed for diagnostic imaging and fluid flow analysis across multiple clinical applications including fetal, abdominal, neuro, musculoskeletal, and vascular imaging. It aids clinicians by providing advanced imaging modes and AI software features like Prostate Volume Assist for workflow improvement and accurate prostate volume measurements.
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 Ultrasound System 1300 is a multi-purpose mobile, software-controlled diagnostic ultrasound system with digital acquisition, processing, and display capabilities. It supports various transducers and modes including Tissue Harmonic imaging, Doppler, Vector Flow Imaging, Strain Elastography, and Contrast Imaging. It includes an AI feature 'Prostate Volume Assist (PVA)' for prostate volume measurement workflow improvement.
Performance
The device underwent extensive bench testing demonstrating equivalence to predicate devices. The AI feature PVA was validated using multiple datasets including clinical images with male patients and passed similarity metrics and clinical expert visual evaluation. No animal or clinical studies were required as substantial equivalence to predicates was established.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/16/2023
4 months - 2
FDA Approval
10/23/2023
Other devices from BK Medical Aps
- Ultrasound System 23002023 • 510K
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