V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System;
Samsung Medison Co., Ltd.These are advanced diagnostic ultrasound systems designed to capture and display high-quality images of different parts of the body. Their use helps doctors diagnose a wide range of conditions in patients of all ages, supporting clinical decisions in diverse settings, such as hospitals and clinics.
Intended Use
The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids for various clinical applications including Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal, Urology, Cardiac (Adult and Pediatric), Thoracic, Ophthalmic, Trans-esophageal (Cardiac), Peripheral vessel, and Dermatology. For use by qualified healthcare professionals in clinical diagnosis.
Technology
These are general-purpose, mobile, software-controlled ultrasound systems capable of multiple imaging modes including 2D, Doppler (Color, Power, Pulsed Wave, Continuous Wave), M-mode, Tissue Doppler, ElastoScan, MV-Flow, multi-image, and 3D/4D imaging. They also support anatomical measurement and have real-time acoustic safety indices.
Performance
The devices underwent non-clinical testing for acoustic output, biocompatibility, software function, cleaning/disinfection, and compliance with thermal, electrical, and mechanical safety standards. All software verification and validation tests were passed. No new clinical studies were required for substantial equivalence.
Predicate Devices
No predicate devices specified
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