# K121249: Multiarray Kit

- Pathway: 510(k) (Special)
- Applicant: Paramed S.R.L.
- Decided: Jun 12, 2012 after 48 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- 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: 11 generations back to K911667 (1991). 38 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033507: MRJ, Paramed S.R.L. (2004) Summary page 2.
- K080098: MRJ Extended, Paramed S.R.L. (2008) Summary page 2.
- K100164: MR Inspire with Extended Kit, Paramed S.R.L. (2010) Summary page 2.

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

## Indications for use
The intended use of the Performance Package is to enable the permanent magnet based MRI systems designed by Paramed (MrJ and MrJ Inspire) to perfornn MR scan of the following districts: C-Spine one dedicated coil (code 0 1-2023), L-Spine two sizes of dedicated coils (codes 01-202 1 and 01-2022), all other joints using a linear single channel coil named ME_wrap (code 01-2024) which is not aimed to specific districts but can fit most joints (such as, for instance, knee, foot, ankle, elbow, wrist, hand ... ). The Performance Package inherits the same limitations of the System to which it is applied which is: only joint pathologies (no tumor, no angiography). The Performance Package enables the MRI System to which it is applied to acquire images of the districts being diagnosed in transverse, sagittal, coronal and oblique cross-sectional directions. The images which are produced correspond to spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon MR parameters (spin-lattice relaxation time (TI), spin-spin relaxation te ff2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically usefuil information.

Source page: https://510kreport.com/device/K121249
Methodology: https://510kreport.com/methodology