# K183222: MAGNETOM Terra

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 15, 2019 after 87 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: 12 generations back to K971684 (1997). 34 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170840: MAGNETOM Terra, Siemens Medical Solutions USA, Inc. (2017) Summary page 7.

## Most influential descendants
- K232322: MAGNETOM Terra; MAGNETOM Terra.X (2024), 0 descendants of its own

## Indications for use
The MAGNETOM Terra 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 Terra 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. The device is intended for patients > 30 kg/66 Ibs.

Source page: https://510kreport.com/device/K183222
Methodology: https://510kreport.com/methodology