# K242258: MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)

- Pathway: 510(k) (Traditional)
- Applicant: Asg Superconductors S.P.A.
- Decided: Nov 26, 2024 after 118 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: 15 generations back to K911667 (1991). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193116: MRopen EVO, Asg Superconductors S.P.A. (2019) Summary page 5.

## Indications for use
Whole body magnetic resonance diagnostic medical device intended for the production of images for diagnostic purposes with transverse, coronal, sagittal and oblique orientation relating to the internal structures of the examined body areas, also including the examination of the brain through the DWI sequence, with limitations regarding cardiac, breast, lung and upper abdominal imaging.

Source page: https://510kreport.com/device/K242258
Methodology: https://510kreport.com/methodology