# K151466: MrOpen

- Pathway: 510(k) (Traditional)
- Applicant: Paramed S.R.L.
- Decided: Oct 15, 2015 after 136 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: 12 generations back to K911667 (1991). 45 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101295: Mropen, Paramed S.R.L. (2010) Summary page 5.
- K990260: OPART, Toshiba America Mri, Inc. (1999) Summary page 5.
- K123708: Spine Coil, Usa Paramed Medical Systems, Inc. (2013) Summary page 5.
- K121249: Multiarray Kit, Paramed S.R.L. (2012) Summary page 5.

## Most influential descendants
- K190524: MRopen 0.5 T (2019), 2 descendants of its own
- K193116: MRopen EVO (2019), 1 descendant of its own
- K242258: MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) (2024), 0 descendants of its own

## Indications for use
MrOpen 03 is indicated for use as a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MrOpen 05 tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the intemal structure of the body. The examinations may be performed botl in weight free (supine or scated position) and weight bearing position. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR paramctcers that determine image appearance are proton deusily, spin-lattice relaxation time (T1), 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/K151466
Methodology: https://510kreport.com/methodology