# K232322: MAGNETOM Terra; MAGNETOM Terra.X

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 22, 2024 after 232 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: 13 generations back to K971684 (1997). 35 ancestors in all.
No later device cites it as a predicate yet.
3 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183222: MAGNETOM Terra, Siemens Medical Solutions USA, Inc. (2019) Summary page 5.

## Indications for use
The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, and that displays the internal structure and/or function of the head or extremities. Other physical parameters derived from the images may also be produced. Additionally, the MAGNETOM system is intended to produce Sodium images for the head and Phosphorus spectroscopic images and/or spectra for whole body, excluding the head. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K232322
Methodology: https://510kreport.com/methodology