Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert
GE HealthcareThe Voluson S Series (including S6, S8, S8t, S10, and S10 Expert) by GE Healthcare is a general-purpose diagnostic ultrasound system designed for use by trained healthcare professionals. It provides high-performance ultrasound imaging and analysis with a focus on real-time 3D/4D acquisition across multiple clinical applications such as obstetrics, abdominal, cardiac, vascular, and musculoskeletal imaging. The system supports a variety of probes and modes including Doppler imaging, elastography, and contrast imaging, helping clinicians visualize and measure various body tissues and fluids in a hospital or clinical setting.
Intended Use
Voluson S6 / Voluson S8 / Voluson S8t / Voluson S10 / Voluson S10 Expert are a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals legally authorized for ultrasound imaging, measurement, display, and analysis of the human body and fluid across multiple clinical applications including fetal/obstetrics, abdominal, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, peripheral vascular, musculoskeletal, transrectal, and transvaginal.
Technology
The system consists of a mobile console with keyboard and touch control panels, color video display, and optional storage and printing devices. It utilizes a variety of linear, curved linear, and matrix phased array transducers with mechanical and electronic scanning providing accurate real-time 3D/4D imaging across all standard ultrasound acquisition modes including Doppler and elastography. It has comprehensive networking and DICOM capability and employs the same fundamental technology as predicate devices.
Performance
The device underwent non-clinical testing including acoustic output, biocompatibility, cleaning, disinfection, thermal, electrical, electromagnetic, and mechanical safety testing, conforming to standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, and ISO 14971. Clinical testing was not required for this submission as the device is substantially equivalent to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/18/2021
1 month - 2
FDA Approval
1/13/2022
Other devices from GE Healthcare
- Precision DL2023 • 510K
- Xeleris V Processing and Review System2023 • 510K
- Voluson P6, Voluson P82022 • 510K
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