# K131737: Supernova C5 Mri System

- Pathway: 510(k) (Traditional)
- Applicant: Liaoning Kampo Medical System Co., Ltd.
- Decided: Oct 23, 2014 after 497 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: 7 generations back to K931544 (1993). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071154: Superstar 0.35T Mri System, Neusoft Medical Systems Co., Ltd. (2007) Summary page 4.

## Indications for use
The Supernova C5 is intended for use as a diagnostic imaging device which can produce transverse, sagittal, coronal and oblique cross-sectional images of the internal structure of the human head, body or extremities. The images produced by MRI system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination

Source page: https://510kreport.com/device/K131737
Methodology: https://510kreport.com/methodology