# K192690: Upgrade Kit MR GUI PRO, MrJ 3300 Plus

- Pathway: 510(k) (Special)
- Applicant: Asg Superconductors S.P.A.
- Decided: Oct 24, 2019 after 28 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: 13 generations back to K911667 (1991). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122034: MRJ 3300, Paramed S.R.L. (2012) Summary page 4.
- K100164: MR Inspire with Extended Kit, Paramed S.R.L. (2010) Summary page 4.
- K033507: MRJ, Paramed S.R.L. (2004) Summary page 4.

## Indications for use
The MRI diagnostic Device is indicated for use as a diagnostic imaging device that produces transverse, sagittal, coronal and oblique cross-sectional images. Such images display the internal structure of the body regions for which it is indicated (shoulder, elbow, hand, wrist, foot, ankle, knee, hip, calf, thigh, arm, forearm, Temporo Mandibular Joint, 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 (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/K192690
Methodology: https://510kreport.com/methodology