# K073457: Mstar MPD4500

- Pathway: 510(k) (Traditional)
- Applicant: Xinaomdt Technology Co., Ltd.
- Decided: Feb 1, 2008 after 53 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
No predicates in its family tree.
10 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K091580: Pica Whole Body Mri System (2009), 5 descendants of its own
- K113281: Mri Sytems (2012), 2 descendants of its own
- K202518: Promaxo MRI System (2021), 1 descendant of its own
- K093984: Pica Whole Body Mri System Model TMS-Mri-3500WB-01 (2010), 1 descendant of its own
- K092230: Mona - Orthopedic Mri System, Model TMS-200ORTH-01 (2009), 1 descendant of its own

## Indications for use
mStar MPF4500 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 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 (T2), and flow.

Source page: https://510kreport.com/device/K073457
Methodology: https://510kreport.com/methodology