# K140253: Magnetom Artis Combi Suite for the Magnetom Aera/Skyra/Skyra with Timtx Trueshape

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 20, 2014 after 48 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: 11 generations back to K971684 (1997). 33 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121434: Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio, Siemens Medi Cal Solutions, Inc. (2012) Summary page 2.
- K123510: Magnetom Skyra, Siemens Medical Solutions USA, Inc. (2013) Summary page 2.

## Most influential descendants
- K142515: MAGNETOM Combi Suite Neurosurgery for the MAGNETOM  Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra (2014), 0 descendants of its own

## Indications for use
The MAGNETOM MR system [Aera/Skyra] is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. 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 MAGNETOM MR system [Aera/Skyra] may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.

Source page: https://510kreport.com/device/K140253
Methodology: https://510kreport.com/methodology