# K030918: Superopen 0.35T, Model NSM-P035

- Pathway: 510(k) (Traditional)
- Applicant: Neusoft Digital Medical Systems Co., Ltd.
- Decided: Apr 1, 2003 after 8 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: 1 generation back to K974212 (1998). 2 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974212: Airis II, Hitachi Medical Systems America, Inc. (1998) Summary page 2.
- K001334: Hitachi Airis II, Hitachi Medical Systems America, Inc. (2000) Summary page 2.

## Most influential descendants
- K071154: Superstar 0.35T Mri System (2007), 3 descendants of its own
- K033315: Superopen 0.23T, Model Nam-P023A (2003), 2 descendants of its own
- K062860: Modification to Superopen 0.23T, Model Nam-P023A (2006), 1 descendant of its own
- K131737: Supernova C5 Mri System (2014), 0 descendants of its own
- K092899: Oper Series Open Type Permanent-Magnet Mri System, Model: Oper-0.3, -0.35, -0.4 (2009), 0 descendants of its own

## Indications for use
The Superopen 0.35T 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 IWR properties that determine the image appearance are proton density, spin-lattice relaxation time (Tl), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be usehl in diagnosis determination. The indications for use are as follows: Anatomical Region: Head, Body, Spine, Extremities Nucleus excited: Proton Diagnostic uses: T1 ,T2, proton density weighted imaging Diffusion weighted imaging MR Angiography Imaging processing Imaging capabilities: 2D, 3D Spin Echo( SE ) Short time inversion recovery (STIR) Fluid attenuated inversion recovery (FLAJR) 2D,3D Field Echo (FE) 2D, 3D Field Echo with Spoiler (FESP) 2D FESP Multi-Slice (FESP-MS) 2D and 3D Field Echo Steady State FID with rephasing gradient (FESS-FID) 2D, 3D Fast Spin Echo (FSE) 2D, 3D MRCP MR Angiography 2D, 3D TOF MTC Echo Planar Imaging (EPI) Multi-shot SE / FE Diffusion

Source page: https://510kreport.com/device/K030918
Methodology: https://510kreport.com/methodology