6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
Esaote S.p.A.The 6450 Ultrasound System (MyLabE80 and MyLabE85) is a versatile diagnostic ultrasound machine designed for various clinical applications including cardiac, vascular, general imaging, and women's health. It supports multiple ultrasound modes like B-mode, Doppler, elastosonography, and 3D/4D imaging to help clinicians visualize and assess internal body structures in real-time, aiding in diagnosis and treatment planning.
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
Uses ultrasonic pulsed Doppler imaging to visualize deep body structures and blood flow. Operates in multiple modes including B-Mode, M-Mode, Doppler, Color Flow Mapping, Elastosonography, 3D/4D imaging. Integrates a second imaging modality for enhanced image assessment (e.g., CT, MR, PET). Equipped with wireless, touchscreen, and ergonomic design.
Performance
Evaluated for acoustic output, biocompatibility, cleaning, safety, and electromagnetic compatibility. Clinical validation of cardiac strain measurement performed with intraclass correlation coefficients (ICCs) validating accuracy against established software references. Device complies with relevant safety standards and has acoustic power levels below FDA limits.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/11/2024
11 months - 2
FDA Approval
5/16/2025
Other devices from Esaote S.p.A.
- 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)2025 • 510K
- 6440 MyLabX902023 • 510K
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