# K130658: Elixbo PM545

- Pathway: 510(k) (Traditional)
- Applicant: Xbo Medical Systems Co., Ltd.
- Decided: Jul 19, 2013 after 129 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 2.

## Indications for use
Elixbo PM545 is indicated for use as magnetic resonance diagnostic device that produces axial, sagittal, coronal and oblique cross sectional images, and that displays the anatomical and pathological information of the head, body, or extremities. When interpreted by a trained physician, these images yield information that can be useful in determining a diagnosis.

Source page: https://510kreport.com/device/K130658
Methodology: https://510kreport.com/methodology