# K140666: MR Elastography

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Jun 13, 2014 after 87 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). 132 ancestors in all.
2 later devices descend from it; 2 cite it directly.
7 of 135 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 2.
- K121434: Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio, Siemens Medi Cal Solutions, Inc. (2012) Summary page 2.

## Most influential descendants
- 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 Elastography is a software and hardware option intended for use on Achieva and Ingenia 1.5T and 3.OT MR Systems for producing images representing tissue stiffness of the abdomen area such as liver and muscle. MR Elastography applies an MR acquisition sequence synchronized with an external source of vibration to produce images representing tissue stiffness (in kiloPascals, kPa). The stiffness image production technique also creates an overlay representing thie reliability of the stiffness image production algorithm.

Source page: https://510kreport.com/device/K140666
Methodology: https://510kreport.com/methodology