# K080098: MRJ Extended

- Pathway: 510(k) (Traditional)
- Applicant: Paramed S.R.L.
- Decided: Mar 10, 2008 after 56 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: 9 generations back to K911667 (1991). 36 ancestors in all.
8 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.
- K063207: S-Scan Mri System, Esaote, S.p.A. (2006) Summary page 2.

## Most influential descendants
- K100164: MR Inspire with Extended Kit (2010), 7 descendants of its own
- K121249: Multiarray Kit (2012), 6 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 intended use of Paramed's MRJ Extended product is for diagnostic nuclear magnetic resonance imaging of hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, Temporo Mandibular Joint (TMJ), C- spine and L-Spine with limitation to joint pathologies (no tumors, no angiogripby), The device produces transverse, sagittal, coronal and oblique crass-sectional images, displaying the internal structure of the limbs and joint being imaged. eThe produced correspond to the spatial distribution of protons (hydrogen nuclei)that checkthe magnetic resonance properties and depen~d upon the MR paramneters (spirflatioe relaxatien time (Ti), spin-spin relaxation time (T2) nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.

Source page: https://510kreport.com/device/K080098
Methodology: https://510kreport.com/methodology