# K082485: Modification to Superopen 0.23T Mri System, Model Nam-P023A

- Pathway: 510(k) (Traditional)
- Applicant: Neusoft Medical Systems Co., Ltd.
- Decided: Sep 9, 2008 after 12 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). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062860: Modification to Superopen 0.23T, Model Nam-P023A, Neusoft Medical Systems Co., Ltd. (2006) Summary page 2.
- K071154: Superstar 0.35T Mri System, Neusoft Medical Systems Co., Ltd. (2007) Summary page 2.

## Indications for use
The Superopen 0.23T 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 MRL 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, Neck, Shoulder, Breast, Wrist, Ankle, Body, Spine, Knee, Extremities Nucleus excited: Proton Diagnostic uses: TI,T2, proton density weighted imaging Diffusion weighted imaging MR Angiography Imaging processing Imaging capabilities: 2D, 3D Spin Echo( SE) Turbo spin echo (TSE) Short time inversion recovery (STIR); Fast STIR, IRFFE, IRSE, Fast IR, IR TSE Fluid attenuated inversion recovery (FLAIR); Fast FLAIR 2D,3D Fast Field Echo (FFE) Tl/T2/N-Fast field echo (FFE); N-Fast filed echo 3D; TI-Fast field echo 3D; Dual echo (DE);DTSE; DSE; MR angiography FE, FFE 3D; Echo Planar Imaging (EPI)

Source page: https://510kreport.com/device/K082485
Methodology: https://510kreport.com/methodology