# K090433: I_Open 0.4T

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Wandong Medical Equipment Co., Ltd.
- Decided: Mar 25, 2009 after 34 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.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
The i Open O.4T system is an open, whole body scanner. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the head, body, or extremities. The images produced by the iOpen O.4T system reflect the special 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 determining a diagnosis. * Anatomical Region: Head, Body, Spine, Extremities * Nucleus excited: Proton - Diagnostic uses: Ti, T2 weighted Proton density weighted MIP-MRA Water suppress imaging fat suppress imaging MRCP * Imaging capabilities: 2D Spin Echo (SE) 2D,3D Fast Spin Echo(FSE) 2D Short Tau Inversion-Recovery (STIR) 2D Fluid Attenuated Inversion Recovery (FLAIR) 2D,3D Rewinded Gradient Echo (2D, 3D Rewinded-GRE) 2D, 3D Spoiled Gradient Echo (2D,3D Spoiled-GRE) 2D,3D Time of Flight Angiography (TOF)

Source page: https://510kreport.com/device/K090433
Methodology: https://510kreport.com/methodology