# K122034: MRJ 3300

- Pathway: 510(k) (Special)
- Applicant: Paramed S.R.L.
- Decided: Dec 6, 2012 after 148 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). 41 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 46 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 1.
- K100164: MR Inspire with Extended Kit, Paramed S.R.L. (2010) Summary page 3.
- K101295: Mropen, Paramed S.R.L. (2010) Summary page 6.
- K121249: Multiarray Kit, Paramed S.R.L. (2012) Summary page 1.

## 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
- K192690: Upgrade Kit MR GUI PRO, MrJ 3300 Plus (2019), 0 descendants of its own

## Indications for use
The MrJ 3300 is indicated for use as a diagnostic imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the following joints: hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, Tempomo Mandibular Joint (TMJ), C-spine, L-Spine with limitation to joint pathologies (no tumors, no angiography). 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 (I), 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/K122034
Methodology: https://510kreport.com/methodology