ULTIMUS Series Ultrasound Diagnostic System
Vinno Technology (Suzhou) Co.,LtdThe ULTIMUS Series Ultrasound Diagnostic System by Vinno Technology (Suzhou) Co., Ltd is a mobile diagnostic ultrasound system designed to assist qualified physicians in imaging and analyzing various parts of the human body and fluids. It supports multiple clinical applications including abdominal, fetal/obstetrics, gynecology, cardiac, vascular, musculoskeletal, and pediatric imaging with advanced imaging modes like 3D/4D, Doppler, elastography, and contrast imaging. The system provides high-quality ultrasound imaging and measurement capabilities intended for hospitals and clinics to enhance diagnostic confidence and patient management.
Intended Use
The ULTIMUS Series Ultrasound Diagnostic System is a general-purpose ultrasound system intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display, and analysis of the human body and fluid. The device is intended for use in hospitals or clinics environments, supporting numerous clinical applications including abdominal, fetal/obstetrics, gynecology, transvaginal, urology (including prostate), transrectal, cardiac (adult and child), peripheral vascular, small organs/parts (thyroid, breast, testicle, musculoskeletal conventional and superficial), pediatrics (including neonatal cephalic), interventional (nerve block and vascular access), and adult cephalic diagnostic ultrasound applications.
Technology
The ULTIMUS Series is a Track 3 diagnostic ultrasound system including a mobile console with height-adjustable control panel and color LCD touch panel and display monitor. It operates with various electronic array transducers including linear, curved, sector/phase, endocavity and real-time 3D probes, supporting multiple imaging modes such as 3D/4D, B, M, PW Doppler, continuous wave Doppler, color Doppler, power Doppler, harmonic imaging, elastography, and contrast imaging. The system includes electronics for transmitting and receiving ultrasound data, ultrasound signal processing, software computing, and hardware for image storage.
Performance
The ULTIMUS Series was evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical, electromagnetic, and mechanical safety. It complies with multiple relevant standards including ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC62359, ISO 10993 series, ISO14971, and others. Clinical studies were not required to support substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/11/2024
9 months - 2
FDA Approval
12/16/2024
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