6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)
Esaote S.p.A.The 6600 Ultrasound System (MyLabA50 and MyLabA70) by Esaote is a multifunctional ultrasound scanner designed for use in various clinical applications such as cardiac, vascular, general imaging, and women's health. It uses advanced ultrasound modes like B-mode, Doppler, elastosonography, and 3D/4D imaging to help clinicians collect, display, and analyze high-quality ultrasound images, supporting diagnosis and patient care. The system includes AI-powered features for automatic obstetric biometric measurements and automatic cardiac measurements, assisting clinicians by enhancing measurement accuracy and workflow efficiency.
Intended Use
The multifunctional ultrasound scanner is used to collect, display and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes.
Technology
The system consists of a control panel assembly with LCD monitor and device electronics enclosed in an ergonomic cart, uses physical ultrasound properties (sound waves above 20 kHz) to image deep tissues by recording echoes, operates with various ultrasound modes including B-Mode, M-Mode, Doppler (Pulsed and Continuous Wave), Color Flow Mapping, Power Doppler, Tissue Velocity Mapping, combined modes, Elastosonography, 3D/4D, and Contrast imaging (CnTI). It also features wireless capability and supports various probe types (Phased Array, Convex, Linear, Doppler, Volumetric).
Performance
Performance testing included acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety testing. AI features (AutoOB and AutoCM) were validated using statistically rigorous acceptance criteria showing high success rates in biometric measurement tasks with training and test datasets. No clinical studies were required for substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/15/2024
8 months - 2
FDA Approval
6/18/2025
Other devices from Esaote S.p.A.
- 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)2025 • 510K
- 6440 MyLabX902023 • 510K
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