# K193116: MRopen EVO

- Pathway: 510(k) (Special)
- Applicant: Asg Superconductors S.P.A.
- Decided: Dec 20, 2019 after 38 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 K911667 (1991). 59 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190524: MRopen 0.5 T, Asg Superconductors S.P.A. (2019) Summary page 7.

## Most influential descendants
- K242258: MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) (2024), 0 descendants of its own

## Indications for use
MRopen EVO is a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen EVO tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The examinations may be performed both in weight free (supine or seated position) and weight bearing position. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (Tl), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.

Source page: https://510kreport.com/device/K193116
Methodology: https://510kreport.com/methodology