Voluson P6, Voluson P8
GE HealthcareThe Voluson P6 and Voluson P8 are general-purpose diagnostic ultrasound systems designed for use by trained healthcare professionals. These systems support a variety of clinical applications, including fetal/obstetrics, abdominal, cardiac, pediatric, vascular, musculoskeletal, and small organ imaging. They provide high-quality real-time imaging, including 3D/4D modes, and Doppler imaging types, aiding clinicians in the diagnosis and monitoring of patients in hospital or clinical settings.
Intended Use
Voluson P6 / Voluson P8 are general-purpose diagnostic ultrasound systems intended for use by qualified healthcare professionals for ultrasound imaging, measurement, display, and analysis of the human body and fluid across a broad range of clinical applications including obstetrics, abdominal, cardiac, pediatric, vascular, musculoskeletal, and small organs.
Technology
The device includes a mobile console with keyboard control panel, color LCD display, and optional image storage and printing. It utilizes a variety of linear, curved linear, and matrix phased array transducers with mechanical and electronic scanning, supporting real-time three-dimensional ultrasound imaging and multiple Doppler modalities, alongside networking and DICOM capability.
Performance
The device was evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and compliance with relevant electrical, thermal, electromagnetic, and mechanical safety standards. The system meets various medical device safety standards including AAMI/ANSI ES60601-1, IEC 60601 series, ISO 10993-1, ISO 14971, and DICOM standards. Clinical studies were not required to support substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/23/2021
2 months - 2
FDA Approval
2/17/2022
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