# K221619: ECHELON Oval V6.2 MRI System

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Healthcare Corporation
- Decided: Jan 26, 2023 after 237 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s summary for it could not be read, so its predicates are not known.

Source page: https://510kreport.com/device/K221619
Methodology: https://510kreport.com/methodology