HM70 EVO Diagnostic Ultrasound System
Samsung Medison CO., LTD.The HM70 EVO Diagnostic Ultrasound System by Samsung Medison is a mobile, software-controlled ultrasound imaging device that captures detailed 2D, 3D, and Doppler ultrasound images across a variety of clinical applications such as obstetrics, cardiology, musculoskeletal, and dermatology. It includes advanced AI-powered features for tasks like nerve detection and uterus assistance to improve diagnostic accuracy, supporting clinicians in making informed patient care decisions.
Intended Use
The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids. Clinical applications include fetal/obstetrics, abdominal, gynecology, pediatric, musculoskeletal, cardiac, peripheral vessel, lung, dermatology, and others. It is for use under supervision of trained healthcare professionals in hospitals, clinics, and similar environments.
Technology
The HM70 EVO is a general purpose mobile, software-controlled ultrasound system capable of 2D, color and power Doppler, M-mode, pulsed and continuous wave Doppler, tissue Doppler, elasto-scan, and real-time 4D imaging. AI-based features include NerveTrack for nerve detection and UterineAssist for uterine image analysis. It uses validated probes and follows established ultrasound imaging standards.
Performance
Performance testing included AI validation on uterus segmentation with high dice scores (~92-96%), nerve detection accuracy of 91.5% with sufficient speed, and robustness across BMI groups. The device passed biocompatibility, acoustic output, electrical, mechanical, and software safety tests. Clinical studies were not required for substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/27/2023
2 months - 2
FDA Approval
12/21/2023
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