# K091669: Open Magnetic Resonance Imaging System, Model MPF3000-Iii

- Pathway: 510(k) (Traditional)
- Applicant: Xioao Mdt Technology Co, Ltd.
- Decided: Jun 18, 2009 after 9 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 K073457 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073457: Mstar MPD4500, Xinaomdt Technology Co., Ltd. (2008) Summary page 1.

## Indications for use
Open Magnetic Resonance Imaging System, MPF3000-111 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 radiationr. The MR system produces transverse, coronal, sagittal and oblique images that display the internal structure of the head, body or extremities. The images produced by the MR 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 (E)and flow.

Source page: https://510kreport.com/device/K091669
Methodology: https://510kreport.com/methodology