EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.The EVO X series of ultrasound systems from Samsung Medison are advanced imaging devices designed to assist healthcare professionals in visualizing internal organs, blood flow, and tissues in real time. They support a wide range of clinical applications from fetal imaging to cardiac and musculoskeletal exams, helping clinicians make faster and more accurate diagnoses.
Intended Use
The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Dermatology, Trans-esophageal (Cardiac), Ophthalmic and Peripheral vessel. It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals (including emergency rooms), private practices, clinics and similar care environment for clinical diagnosis of patients.
Technology
General purpose, mobile, software-controlled ultrasound systems that acquire and display ultrasound data in various modes (2D, Doppler, M-mode, elastography, multi-image, and more), with the ability to measure anatomical structures and analyze data for clinical diagnosis. Includes real-time acoustic output display and supports multiple transducers and network connectivity (Wi-Fi, Bluetooth).
Performance
The device was evaluated through non-clinical tests including acoustic output, biocompatibility, software function, cleaning/disinfection effectiveness, as well as thermal, electrical, electromagnetic, and mechanical safety. The system conforms to applicable FDA-recognized medical device safety standards. No new clinical studies were required; substantial equivalence was demonstrated using non-clinical (bench) data.
Predicate Devices
No predicate devices specified
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