# K151074: Magnetic Reasonance Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Magspin Instrument Co.,Ltd
- Decided: Dec 22, 2015 after 244 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: 11 generations back to K911667 (1991). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092469: O-Scan MR System, Esaote, S.p.A. (2009) Summary page 6.

## Indications for use
The Magnetic Resonance Imaging System produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It’s intended for imaging portions of the arm, including the hand, wrist, forearm, elbow, and imaging of the shoulder, and imaging portion of the leg, including the foot, ankle, calf and knee, but excluding the thigh. Magspin’s magnetic resonance imaging system is a fixed system, it produces images correspond to the spatial distribution of protons (hydrogen nuclei) that embodies magnetic resonance properties of human body and is weighted by the MR parameters such as spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and “chemical shift”. When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.

Source page: https://510kreport.com/device/K151074
Methodology: https://510kreport.com/methodology