# K033507: MRJ

- Pathway: 510(k) (Traditional)
- Applicant: Paramed S.R.L.
- Decided: Jan 20, 2004 after 76 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.
9 later devices descend from it; 5 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K080098: MRJ Extended (2008), 8 descendants of its own
- 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

## Indications for use
The intended use of Paramed's MRJ product is for diagnostic MRI imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, TMJ and cervical spine with limitation to joint pathologies - no tumors, no angiography. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend on the MR parameters (spin-lattice relaxation time - T1, 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/K033507
Methodology: https://510kreport.com/methodology