# K131896: Supervan 1.5T Magnetic Resonance Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Anke Medical System Co., Ltd.
- Decided: Feb 28, 2014 after 248 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: 3 generations back to K031815 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
2 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052013: Achieva 1.5T & Inera 1.5T Family, Philips Medical Systems Nederland B.V. (2005) Summary page 2.

## Indications for use
SuperVan 1.5T Magnetic Resonance Imaging System is a MRI system that produces transversal, sagittal and coronal and oblique cross-section images of the internal structure of the whole body. The images produced by the SuperVan 1.5T 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. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K131896
Methodology: https://510kreport.com/methodology