# K201389: Resoundant Acoustic Driver System

- Pathway: 510(k) (Traditional)
- Applicant: Resoundant, Inc.
- Decided: Jul 10, 2020 after 44 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: 13 generations back to K935595 (1995). 100 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083421: MR-Touch Option, Ge Medical Systems, LLC (2009) Summary page 5.

## Most influential descendants
- K242006: SureWave Elastography (Q7000225) (2025), 0 descendants of its own

## Indications for use
The Resoundant Acoustic Driver System is intended for use with magnetic resonance diagnostic devices (MRDD) that include legally marketed MR elastography capabilities. It is indicated for generating acoustic vibrations in the body during an MRI exam, in order to assess tissue elasticity for diagnostic purposes as part of magnetic resonance elastography (MRE). When interpreted by a trained physician, this information can be useful in determining a diagnosis.

Source page: https://510kreport.com/device/K201389
Methodology: https://510kreport.com/methodology