Voluson SWIFT; Voluson SWIFT+
GE Medical Systems Ultrasound & Primary Care Diagnostic, LLCThe Voluson SWIFT and Voluson SWIFT+ are advanced diagnostic ultrasound systems used by healthcare professionals for imaging and analyzing the human body and fluids. These systems support multiple clinical applications including fetal/obstetrics, abdominal, cardiac, musculo-skeletal, and vascular imaging using various ultrasound modes such as B-mode, Doppler, 3D/4D imaging, and elastography. They feature AI-assisted tools like Auto-Caliper for improved measurement accuracy, enhancing clinicians' ability to perform exams efficiently and precisely in hospital or clinical settings.
Intended Use
General-purpose diagnostic ultrasound system for imaging, measurement, display and analysis of the human body and fluids including several clinical applications.
Technology
The system consists of a mobile console with control panel and full touch monitor, supports a variety of transducers including mechanical and electronic scanning types. It offers multiple ultrasound modes including B, M, AMM, PW Doppler, Color Doppler, Power Doppler, 3D/4D imaging, elastography, and combines advanced digital acquisition, processing, and display capabilities with comprehensive networking and DICOM.
Performance
The device was tested with non-clinical and safety tests including acoustic output, biocompatibility, electrical and mechanical safety, and complies with multiple standards such as IEC and ISO norms. It also underwent verification of AI feature Auto-Caliper for follicle measurement with a success rate of 70% or higher across diverse datasets from multiple countries and clinical experts reviewed the AI outputs.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/8/2023
4 months - 2
FDA Approval
6/20/2023
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