# K083421: MR-Touch Option

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Jul 24, 2009 after 247 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: 12 generations back to K935595 (1995). 99 ancestors in all.
4 later devices descend from it; 2 cite it directly.
4 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052293: GE 1.5T and 3.0T Signa HDX MR System, Ge Medical Systems, LLC (2005) Summary page 1.
- K083095: Sonixtouch Ultrasound System, Ultrasonix Medical Corporation (2008) Summary page 1.

## Most influential descendants
- K140666: MR Elastography (2014), 2 descendants of its own
- K201389: Resoundant Acoustic Driver System (2020), 1 descendant of its own
- K242006: SureWave Elastography (Q7000225) (2025), 0 descendants of its own
- K220018: MR Elastography; MZEK-001A (2022), 0 descendants of its own

## Indications for use
MR-TouchTM is a software and hardware option intended for use with GE Signa® MR systems. It is indicated for magnetic resonance imaging of the human body. MR-TouchTM generates transverse sectional information related to the relative stiffness of soft tissue. It consists of hardware as well as acquisition and reconstruction software. The hardware components induce vibrations into the scan subject. The MR-TouchTM acquisition software is an evolutionary improvement to the gradient echo sequence. The sequence synchronizes the induced vibrations to acquire a series of phase-contrast images over time. The phase-contrast imaging technique measures motion or displacement. The displacement from the induced vibrations is detected using the time-series of phase-contrast images. The displacement information is reconstructed and presented as strain wave and relative stiffness images. When used with a GE Signa® MR system, MR-TouchTM is capable of producing transverse images of internal body structures such as muscle and liver. When interpreted by a trained physician, these images may provide information that can be useful in determining a diagnosis.

Source page: https://510kreport.com/device/K083421
Methodology: https://510kreport.com/methodology