# K073362: Mropen

- Pathway: 510(k) (Traditional)
- Applicant: Paramed S.R.L.
- Decided: May 23, 2008 after 175 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.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K101295: Mropen (2010), 7 descendants of its own
- K123708: Spine Coil (2013), 4 descendants of its own
- K122034: MRJ 3300 (2012), 4 descendants of its own
- K151466: MrOpen (2015), 3 descendants of its own
- K190524: MRopen 0.5 T (2019), 2 descendants of its own

## Indications for use
The MROpen is a total body magnetic resonance imaging device. It is indicated for use as a diagnostic total body inaging device that produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. 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 (Ti), 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/K073362
Methodology: https://510kreport.com/methodology