Digital Color Doppler Ultrasound System (P60 Series)
Sonoscape Medical Corp.The Digital Color Doppler Ultrasound System (P60 Series) by Sonoscape Medical Corp. is an advanced ultrasound imaging instrument that uses multiple modes including color Doppler and AI-based features to help clinicians evaluate a wide range of body regions and conditions with high detail and accuracy. It supports AI-powered automatic recognition and measurement to aid in fetal ultrasound examinations and other diagnostic exams, improving workflow efficiency and diagnostic performance.
Intended Use
The Digital Color Doppler Ultrasound System is a general-purpose ultrasonic imaging instrument intended for use by appropriately trained healthcare professionals in hospital for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculoskeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph (Cardiac), Laparoscopic, OB/Gyn and Urology.
Technology
The system uses ultrasound to transmit energy into the patient body and receives echoes to create images using multiple modes such as B-Mode, Doppler, Tissue Harmonic Imaging, 3D/4D imaging, Elastography, and Contrast imaging. It includes AI-based functions such as S-FetusAI for automatic fetal ultrasound image recognition and measurement, operating on a mobile console with a touchscreen and supports various probes (linear, convex, phased array).
Performance
Performance testing included acoustic output, biocompatibility, electrical and mechanical safety tests, conducted per medical device standards. AI feature S-FetusAI was evaluated with a large independent image dataset and clinical trials comparing AI measurement and recognition to manual expert analysis, demonstrating that S-FetusAI achieves high accuracy (>85% acceptance criteria) and is non-inferior to manual methods.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/3/2024
6 months - 2
FDA Approval
1/17/2025
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