SureWave Elastography (Q7000225)
Quality Electrodynamics, LLCSureWave Elastography is an accessory device for Siemens MRI systems that generates shear wave vibrations during MRI scans to create images showing tissue stiffness. This advanced imaging helps physicians diagnose tissue abnormalities by providing detailed stiffness maps alongside traditional MRI images.
Intended Use
The SureWave Elastography device is intended for use with Siemens 1.5T and 3.0T MRI systems to generate shear wave vibrations in the body of adult patients during an MRI exam that are translated into images representing tissue stiffness. The images may be used for diagnostic purposes when interpreted by a trained physician.
Technology
This device includes hardware that induces shear wave vibrations on the patient via a transducer mounted on a mobile tower with flexible rotating axes. It also includes reconstruction software that uses MRI-acquired data to create images showing tissue stiffness in 2D and 3D, synchronized with the vibrations.
Performance
Bench testing with elasticity phantoms demonstrated that SureWave Elastography achieves stiffness measurements that are as accurate or more accurate than predicate devices with good repeatability within 10%. Volunteer studies with 22 healthy adults showed strong agreement with predicate methods, confirming equivalence. Safety and biocompatibility testing were also completed successfully.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/9/2024
7 months - 2
FDA Approval
2/12/2025
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