# K101295: Mropen

- Pathway: 510(k) (Traditional)
- Applicant: Paramed S.R.L.
- Decided: Jul 28, 2010 after 79 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: 1 generation back to K073362 (2008). 1 ancestor in all.
7 later devices descend from it; 3 cite 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)
- K073362: Mropen, Paramed S.R.L. (2008) Summary page 2.

## Most influential descendants
- 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
- K193116: MRopen EVO (2019), 1 descendant of its own

## Indications for use
The MR Open is indicated for use as a diagnostic total body imaging device with the following limitation: no angiography, no cardiac imaging, no breast imaging. MR Open tomograph 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/K101295
Methodology: https://510kreport.com/methodology