# K220018: MR Elastography; MZEK-001A

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Systems Corporation
- Decided: Mar 3, 2022 after 57 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). 147 ancestors in all.
No later device cites it as a predicate yet.
11 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140666: MR Elastography, Philips Medical Systems Nederland B.V. (2014) Summary page 5.
- K193215: Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems, Philips Medical Systems Nederland B.V. (2020) Summary page 5.

## Indications for use
MR Elastography is an optional package for Canon Medical Systems magnetic resonance imaging (MRI) systems. This option allows the user to obtain an image that reflects the stiffness, in kPa, of body tissue such as liver and muscle.

Source page: https://510kreport.com/device/K220018
Methodology: https://510kreport.com/methodology