# K242006: SureWave Elastography (Q7000225)

- Pathway: 510(k) (Traditional)
- Applicant: Quality Electrodynamics, LLC
- Decided: Feb 12, 2025 after 218 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K935595 (1995). 134 ancestors in all.
No later device cites it as a predicate yet.
7 of 135 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201389: Resoundant Acoustic Driver System, Resoundant, Inc. (2020) Summary page 5.
- K140666: MR Elastography, Philips Medical Systems Nederland B.V. (2014) Summary page 5.

## Indications for 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.

Source page: https://510kreport.com/device/K242006
Methodology: https://510kreport.com/methodology