# K092237: NSM-S15 System

- Pathway: 510(k) (Traditional)
- Applicant: Neusoft Medical Systems Co., Ltd.
- Decided: Sep 9, 2009 after 48 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). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071925: Magnetom Essenza, Siemens Medical Solutions USA, Inc. (2007) Summary page 2.
- K071154: Superstar 0.35T Mri System, Neusoft Medical Systems Co., Ltd. (2007) Summary page 2.

## Indications for use
The NSM-S15 product is an imaging device, and is intended to provide the physician with physiological and clinical information obtained non-invasively and without the use of ionizing radiation. The MRI system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the 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 (TI), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination. The indications for use are as follows: Anatomical Region: Head, Shoulder, Breast, Wrist, Body, Spine, Knee, Extremities Nucleus excited: Proton Diagnostic uses: TI, T2, proton density weighted imaging Diffusion weighted imaging MR Angiography Imaging processing Imaging capabilities: Spin Echo (SE and 3D SE) Fast Field Echo (FFE and 3D FFE) Inversion Recovery (IRFFE, IRSE) TI-FFE, T2-FFE, N-FFE (2D and 3D) IR prepared TI-FFE3D Dual Echo (DE) and Dual Spin Echo (DSE) Dual Fast Field Echo (DFFE) Turbo Spin Echo (TSE, 2D and 3D) Single-shot TSE Dual Contrast Turbo Spin Echo (DTSE) Driven Equilibrium Turbo Spin Echo IR TSE T2 Balance Fast Field Echo (B-FFE and 3D B-FFE) Diffusion-Weighted Imaging with DWISE and Fast DWISE Echo Planar Imaging (EPI)

Source page: https://510kreport.com/device/K092237
Methodology: https://510kreport.com/methodology