Voluson Signature 20, Voluson Signature 18
GE Medical Systems Ultrasound and Primary care Diagnostics,The Voluson Signature 20 and Voluson Signature 18 are advanced diagnostic ultrasound systems designed primarily for general radiology and specialized OB/GYN use. They provide high-performance ultrasound imaging, including real-time 3D/4D acquisition and various Doppler imaging modes, to help clinicians visualize and analyze the human body and fluids. These systems support multiple clinical applications such as fetal imaging, abdominal, cardiac, vascular, musculoskeletal, and more, aiding in diagnosis and patient care in hospital or clinical settings.
Intended Use
Voluson Signature 18 / Voluson Signature 20 system are general-purpose diagnostic ultrasound systems intended for use by qualified and trained healthcare professionals authorized or licensed by law for ultrasound imaging, measurement, display and analysis of the human body and fluid. Clinical applications include fetal/obstetrics, abdominal (including renal and gynecology/pelvic), pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, peripheral vascular, musculo-skeletal, transrectal (including urology/prostate), and transvaginal.
Technology
The system is a full-featured ultrasound device providing high performance imaging and analysis, real-time 3D/4D imaging, various Doppler modes, elastography, and comprehensive networking and DICOM capability. It uses linear, curved linear, and matrix phased array transducers, including mechanical and electronic scanning, for real-time three-dimensional imaging supporting all standard acquisition modes.
Performance
The device underwent non-clinical tests including acoustic output, biocompatibility, cleaning and disinfection, thermal, electrical, electromagnetic and mechanical safety, demonstrating conformance with medical device safety standards. The device did not require clinical studies to support substantial equivalence. Quality assurance included risk analysis, requirement reviews, design reviews, unit and integration testing, performance and safety verification.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/17/2023
3 months - 2
FDA Approval
3/7/2024
Other devices from GE Medical Systems Ultrasound and Primary care Diagnostics,
- Vivid Pioneer2025 • 510K
- Versana Premier; Versana Premier Lotus; LOGIQ F2024 • 510K
- LOGIQ Totus2023 • 510K
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